**I. [GENERAL INFORMATION]{.underline}**

**Device Generic Name:** Excimer Laser

**Device Trade Name:** Bausch & Lomb TECHNOLAS^®^217A Excimer Laser
System

**Applicant's Name and Address:** Bausch & Lomb, Inc.

#  180 E. Via Verde Drive

San Dimas, California 91773 USA

####  Date of Panel Recommendation: None

#### 

####  PMA Number: P990027/S4

**Date of Notice of Approval** February 25, 2003

to Applicant:

The Bausch & Lomb TECHNOLAS 217A Excimer Laser System was approved on
February 23, 2000 under PMA 990027/S2 for the indication of
photorefractive keratectomy for the reduction or elimination of myopia
ranging from --1.00 D to --7.00 D spherical myopia with our without
[\<]{.underline} -3.00 astigmatism. An expansion of the indication
statement was approved on May 17, 2002 for the reduction or elimination
of myopic astigmatism up to --12.00 D MRSE, with sphere between \> -7.00
D to --10.99 D and cylinder between 0.00 and \<03.00. The sponsor
submitted the current supplement to request expansion of the indication
statement to include hyperopia and hyperopic astigmatism. Clinical data
to support this indication are provided in this summary. The
pre-clinical test results were presented in the original PMA
application. For more information on the data that supported the
approved indication, the summary of safety and effectiveness data (SSED)
for P990027/S4 should be referenced. Written requests for copies of the
SSED can be obtained from the Dockets Management Branch (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville,
Maryland 20857. The summary can also be found on the FDA CDRH Internet
Home Page located at <http://www.fda.gov/cdrh/pmapage.html>.

**II. [INDICATIONS FOR USE]{.underline}**

The Bausch & Lomb TECHNOLAS 217A Excimer Laser System is indicated for
use in laser assisted in-situ keratomileusis (LASIK) treatments for:

-   The reduction or elimination of low-to-moderate naturally occurring
    hyperopia up to +4.00 dipoters (D) MRSE, with sphere between +1.00
    to +4.00 D with or without refractive astigmatism up to +2.00 D at
    the spectacle plane.

-   In patients with documented evidence of a change in manifest
    refraction of less than or equal to 0.50 diopters (in both cylinder
    and sphere components) for at least one year prior to the date of
    the pre-operative examination.

-   In patients who are 21 years of age or older.

# **[CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS]{.underline}**

A.  **Contraindications\
    **

LASIK surgery is contraindicated in:

-   Patients with collagen vascular, autoimmune, or immunodeficiency
    diseases;

-   Pregnant or nursing women;

-   Patients with signs of keratoconus;

-   Patients who are taking one or both of the following medications:
    isotretinoin (Accutane), or amiodarone hydrochloride (Cordarone).

#########  {#section-1 .unnumbered}

######### **B.** **Warning and Precautions** {#b.-warning-and-precautions .unnumbered}

Please refer to the Professional Use information and the Patient
Information booklet for a complete list of warning and precautions.

######## **[DEVICE DESCRIPTION]{.underline}**

> The TECHNOLAS^®^217A Excimer Laser System is designed for the
> correction of refractive error by reshaping the surface of the cornea.
> Corneal reshaping is accomplished by ablating precise amounts of
> corneal tissue with high-energy ultraviolet light from a pulsed
> Argon-Fluoride excimer laser system. The desired ablation profile is
> based upon the thin lens equations. The TECHNOLAS^®^217A uses a small
> diameter spot in a scanning mode to create the type of correction
> desired hyperopia or astigmatism.
>
> The TECHNOLAS 217A Excimer Laser system for hyperopic astigmatism uses
> an optical zone that is selectable between 5.0 mm and 6.0 mm and a
> blend zone of 1.90mm for spherical hyperopia and 1.75 mm for hyperopic
> astigmatism. and the Laser is locked out for refractive corrections
> greater 4.00D sphere and greater than 2.00D cylinder. The software
> used in the clinical trial was 2.9994A. The final commercial release
> version for hyperopic astigmatism, incorporating the changes made
> during PMA review, is software version 3.14A.
>
> **The TECHNOLAS^®^217A Excimer Laser System consists of the following
> components:**
>
> **A. Laser System**

+-----------+----------------------------------------------------------+
| #### L    | The laser unit consists of the laser head (discharge     |
| aser Unit | system), which contains the optical resonator and a      |
|           | discharge chamber, which is filled with a premix of      |
|           | argon, fluorine, and a buffer of other noble gases.      |
+-----------+----------------------------------------------------------+
| Control   | The control unit contains the personal computer that     |
| Unit      | uses a software algorithm to calculate the number and    |
|           | location of laser pulses required to achieve the desired |
|           | correction.                                              |
+-----------+----------------------------------------------------------+
| #### T    | The tower unit provides the stable holding construction  |
| ower Unit | for the optical system of the TECHNOLAS^®^217A Excimer   |
|           | Laser. The tower unit contains the optical elements that |
|           | condition the laser beam to the appropriate              |
|           | characteristics. The tower also contains the             |
|           | visualization optics (the operating microscope) and the  |
|           | positioning and fixation optics for properly locating    |
|           | and monitoring the progress of the ablation. There is a  |
|           | distance of 21 cm ("working distance") between the       |
|           | focusing point on the cornea and the laser arm.          |
+-----------+----------------------------------------------------------+
| Operating | > The operating elements of the TECHNOLAS^®^217A Excimer |
| Elements  | > Laser System consist of two joysticks for movement of  |
|           | > the patient bed in all axes and other operating        |
|           | > elements and external connectors.                      |
+-----------+----------------------------------------------------------+
| Bed Unit  | The bed unit allows for accurate positioning of the      |
| and Chair | patient during the surgical procedure while the          |
|           | operating chair allows the surgeon to adjust his/her     |
|           | position at the operating microscope.                    |
+-----------+----------------------------------------------------------+

> **TECHNOLAS^®^217A Excimer Laser Specifications**

# Laser Type Argon Fluoride

> Laser Wavelength 193 nm
>
> Laser Pulse Duration 18 nanoseconds
>
> Laser Head Repetition Rate 50 Hz
>
> Effective Corneal Repetition Rate 12.5 Hz

#### Fluence (at the eye) 120 mJ/cm^2^

# Range of Ablation Diameter 2.0 to 2.05 mm

> **B. Microkeratome**
>
> The microkeratome is an instrument that creates a hinged corneal flap
> (lamellar flap) prior to the laser ablation procedure. The
> microkeratome is commercially available and cleared for marketing via
> premarket notification. The device used in this study consists of a
> sterilization/storage tray which includes the microkeratome head, a
> left/right eye adapter, suction ring, suction handle, and blade
> insertion tool. The microkeratome motor, tonometer, cleaning brush,
> disposable blades, black suction ball, power/suction supply unit with
> vacuum and motor footswitch and power cords are provided as separate
> components and accessory stand and equipment suitcase which complete
> the system.

### [ALTERNATIVE PRACTICES OR PROCEDURES]{.underline}

> Alternative methods of correcting farsightedness (hyperopia) include:
> glasses, contact lenses, photorefractive keratectomy (PRK), incisional
> refractive keratotomy (RK), lamellar refractive keratotomy, or other
> types of refractive surgery.

V.  **[MARKETING HISTORY]{.underline}**

> Over 500 TECHNOLAS^®^217 Excimer Laser Systems have been installed in
> the following countries: Argentina, Australia, Austria, Belgium,
> Brazil, Canada, Chile, China, Colombia, Czech Republic, Finland,
> France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy,
> Japan, Jordan, Korea, Malaysia, Mexico, New Zealand, Philippines,
> Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain,
> Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United
> States and Venezuela.
>
> The TECHNOLAS^®^217A Excimer Laser System has not been withdrawn from
> marketing for any reason relating to the safety and effectiveness of
> the device.

VI. **[POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH]{.underline}**

###  {#section-2 .unnumbered}

Potential adverse reactions associated with LASIK include: loss of best
spectacle corrected visual acuity, worsening of patient complaints such
as dry eyes, double vision, sensitivity to bright lights, increased
difficulty with night vision, fluctuations in vision, increase in
intraocular pressure, corneal haze, secondary surgical intervention,
corneal infiltrate or ulcer, corneal epithelial defect, corneal edema,
problems associated with the flap including a lost, misplaced or
misaligned flap, retinal detachment, and retinal vascular accidents.

VII. **[SUMMARY OF PRECLINICAL STUDIES]{.underline}**

> Please refer to the SSED of the original PMA P990027

VIII. **[SUMMARY OF CLINICAL STUDIES]{.underline}**

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A.  **Objectives**

    The objective of this study was to demonstrate the safety and
    effectiveness of the Bausch & Lomb TECHNOLAS 217A Excimer Laser
    System for the reduction or elimination of low-to-moderate naturally
    occurring hyperopia of +1.00 to +4.00 diopters with or without
    refractive astigmatism up to +2.00 diopters when used as part of the
    LASIK surgical procedure. In this study, the maximum amount of
    sphere treated was +4.00 D, and the maximum amount of cylinder
    treated was +2.00 D.

B.  **Study Design**

    The data for this report were gathered from a prospective,
    open-label, non-randomized, multi-center clinical evaluation
    conducted in the United States of America for the indications of
    +1.00 to +4.00 D of hyperopia and up to +2.00 D of astigmatism when
    used in the procedure known as LASIK. Since the TECHNOLAS 217A laser
    already had PMA approval for marketing based on previously submitted
    safety and effectiveness data for myopia and astigmatic myopia, the
    sample size was based on the demonstration of
    [effectiveness]{.underline} for hyperopia treatments rather than on
    primary safety outcomes. A total of 358 eyes were enrolled (357
    actually treated). There were 290 eyes (233 non-monovision and 57
    monovision) with 6 months of follow-up data. Based on the sample
    size calculations provided in the original protocol, at least 196
    non-monovision-treated eyes would be required to demonstrate
    effectiveness. In this report, effectiveness results are provided
    for 233 non-monovision-treated eyes with at least 6 months of
    follow-up data. Safety data are provided for all 358 eyes enrolled
    in the study.

C.  **Inclusion and Exclusion Criteria\
    **

> Study Inclusion Criteria:
>
> To be enrolled in the study, patients needed to meet these conditions:
> have +1.00 to +4.00D of hyperopia with +2.00D or less of refractive
> astigmatism; less than 0.75D of latent hyperopia as determined by the
> difference between preoperative manifest and cycloplegic refractions;
> be willing to have full distance correction or monovision; presbyopic
> patients must tolerate and accept monovision during a trial monovision
> correction using either contact lenses or spectacles, have a white to
> white measurement of not less than 11.0mm; have a stable refraction
> for the past year; discontinue use of contact lenses at least 2 weeks
> for hard contracts and 1 week for soft lenses prior to surgery; hard
> contact wearers must have two central keratometry readings and two
> manifest refractions taken at least one week apart that do not differ
> by more than 0.50D; with visual acuity correctable to at least 20/40;
> be at least 21 years of age, be willing and able to return for
> scheduled follow-up examinations; provide written informed consent.
>
> Exclusion Criteria -- All eyes to be Treated
>
> Patients not meeting the above inclusion criteria were excluded from
> the study,in addition, subjects who exhibited any of the following
> conditions were excluded: history of anterior segment pathology,
> including cataracts; patients co-managed by ophthalmologist or
> optometrist not approved as a B&L laser investigator; residual,
> recurrent, active ocular or uncontrolled eyelid disease, or any
> corneal abnormality (specifically, recurrent corneal erosion, severe
> basement membrane disease); ophthalmoscopic signs of keratoconus (or
> keratoconus suspect); unstable (distorted/not clear) corneal mires on
> central keratometry readings; blind in the fellow eye; previous
> intraocular or corneal surgery; history of herpes zoster or herpes
> simplex keratitis; history of steroid-responsive rise in intraocular
> pressure, glaucoma, or preoperative IOP \>21 mm Hg; diabetes,
> diagnosed autoimmune disease, connective tissue disease or clinically
> significant atopic syndrome; chronic systemic corticosteroid or other
> immunosuppresive therapy, and immunocompromised patients; pregnant,
> lactating, or child-bearing potential and not practicing a medically
> approved method of birth control; sensitivity to planned study
> medications; simultaneous participation in other ophthalmic drug or
> device clinical trial.
>
> **D. Study Plan, Patient Assessments and Efficacy Criteria**
>
> All subjects were expected to return for follow-up examinations at 1
> day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months, 18
> months and 24 months postoperatively.
>
> Subjects were permitted to have second eyes (fellow eyes) treated no
> sooner than 7 days after the first eye surgery. In, addition, subjects
> were eligible for retreatment no sooner than 3 months after the
> original surgery and only if refraction was stable after treatment.
> Retreatment would not be performed as a part of the protocol.
>
> Preoperatively, the subjects' medical and ocular histories were
> recorded. The objective parameters measured during the study included:
> uncorrected visual acuity, best spectacle corrected visual acuity,
> manifest refraction, intraocular pressure, corneal pachymetry, slit
> lamp examination of the anterior segment, fundus examination,
> computerized corneal topography and subjective self evaluation
> questionnaire.
>
> The primary efficacy variables for this study were improvement of UCVA
> based on the pre-treatment goal of the procedure and predictability of
> manifest refraction.

E.  **Study Period, Investigational Sites, and Demographics Data**

> **1. Study Period and Investigational Sites**
>
> Subjects were treated between May 1999 to August 2001. The database
> for this PMA supplement reflected data collected through March 18.
> 2002. A total of 358 eyes were treated at eight sites.

2.  **Demographics**

> Demographic data for all treated eyes grouped by treatment type are
> presented below in Table 1.

**Table 1**

**Demographics --- All Treated Eyes**

  ------------------ ---------------- ------------ ---------------- ------------- ---------------- ------------ ----------------
  **Demographics**                    **Treated                     **Treated for                  **All        
                                      for                           Astigmatic                     Treated      
                                      Spherical                     Hyperopia**                    Eyes**       
                                      Hyperopia                                                                 
                                      Only**                                                                    

                                      **Number**   **Percentage**   **Number**    **Percentage**   **Number**   **Percentage**

  NUMBER OF EYES &                    211 Eyes of                   147 Eyes of                    358 Eyes of  
  SUBJECTS                            128 Enrolled                  96 Enrolled                    194 Enrolled 
                                      Subjects                      Subjects                       Subjects     

  GENDER                                                                                                        

                     Male             104          49.3%            74            50.3%            178          49.7%

                     Female           107          50.7%            73            49.7%            180          50.3%

  RACE                                                                                                          

                     White            208          98.6%            142           96.6%            350          97.8%

                     Black            1            0.5%             3             2.0%             4            1.1%

                     Other            2            0.9%             2             1.4%             4            1.1%

  SURGICAL EYE                                                                                                  

                     Right            100          47.4%            79            53.7%            179          50.0%

                     Left             111          52.6%            68            46.3%            179          50.0%

  AGE (in years)                                                                                                

                     Mean             52.8 ( 7.5)                   53.6 ( 9.5)                    53.1 ( 8.4)  

                     Minimum, Maximum 23.4, 68.9                    23.9, 69.0                     23.4, 69.0   
  ------------------ ---------------- ------------ ---------------- ------------- ---------------- ------------ ----------------

19. **F. Data Analysis and Results**

> **1. Preoperative Characteristics\
> **
>
> Presented in Table 2 are the preoperative refraction parameters for
> all treated eyes.

**Table 2**

**Preoperative Refraction Parameters**

**All Treated Eyes**

**Stratified by Sphere and Cylinder Components**

  ------------------ ------------- -------- ------------- -------- ------------- ------- ----------- ---------
  **Manifest**       **Manifest                                                          **Total**   
                     Cylinder**                                                                      

  **Sphere**         **Mean (SD):                                                                    
                     0.50 (0.46),                                                                    
                     Range: 0.00                                                                     
                     to 2.00**                                                                       

  **Mean (SD): 1.92  **0.00-0.99            **1.00-1.74            **1.75-2.00                       
  (0.79)**           D**                    D**                    D**                               

  **Range: 0.50 to   **n/N**       **%**    **n/N**       **%**    **n/N**       **%**   **n/N**     **%**
  4.00**                                                                                             

  0.00-0.50 D        2/358         (0.6)    1/358         (0.3)    0/358         (0.0)   3/358       (0.8)

  0.51-1.00 D        40/358        (11.2)   8/358         (2.2)    1/358         (0.3)   49/358      (13.7)

  1.01-1.50 D        85/358        (23.7)   21/358        (5.9)    3/358         (0.8)   109/358     (30.4)

  1.51-2.00 D        56/358        (15.6)   9/358         (2.5)    4/358         (1.1)   69/358      (19.3)

  2.01-2.50 D        53/358        (14.8)   8/358         (2.2)    0/358         (0.0)   61/358      (17.0)

  2.51-3.00 D        28/358        (7.8)    3/358         (0.8)    2/358         (0.6)   33/358      (9.2)

  3.01-3.50 D        21/358        (5.9)    1/358         (0.3)    1/358         (0.3)   23/358      (6.4)

  3.51-4.00 D        9/358         (2.5)    1/358         (0.3)    1/358         (0.3)   11/358      (3.1)

  Total              294/358       (82.1)   52/358        (14.5)   12/358        (3.4)   358/358     (100.0)

  N = Total number                                                                                   
  of eyes treated                                                                                    
  for astigmatic                                                                                     
  hyperopia.                                                                                         

  1 eye                                                                                              
  (3.500.75x15) was                                                                                  
  reported with an                                                                                   
  aborted procedure.                                                                                 

  79 eyes were                                                                                       
  treated for                                                                                        
  monovision.                                                                                        
  ------------------ ------------- -------- ------------- -------- ------------- ------- ----------- ---------

2.  **Post-operative Characteristics and Results\
    **

> **a. Accountability**
>
> Accountability for all treated eyes across the study visit schedule is
> presented in Table 3.

**Table 3**

**Accountability --- All Treated Eyes**

  ---------------- --------------- ----- --------- ---------- ---------- ---------- ----------
  **Status**                             **1       **3        **6        **9        **≥ 12
                                         Month**   Months**   Months**   Months**   Months**

  Available for                    n/N   333/358   343/358    290/358    222/358    178/358
  Analysis                         (%)   (93.0%)   (95.8%)    (81.0%)    (62.0%)    (49.7%)

                                                                                    

  Discontinued\*                   n/N   1/358     1/358      1/358      13/358     19/358
                                   (%)   (0.3%)    (0.3%)     (0.3%)     (3.6%)     (5.3%)

                                                                                    

  Active                           n/N   0/358     0/358      48/358     50/358     152/358
                                   (%)   (0.0%)    (0.0%)     (13.4%)    (14.0%)    (42.5%)

  (Not yet                                                                          
  eligible for the                                                                  
  interval)                                                                         

                                                                                    

  Lost to                          n/N   0/358     0/358      0/358      6/358      6/358
  Follow-up†                       (%)   (0.0%)    (0.0%)     (0.0%)     (1.7%)     (1.7%)

                                                                                    

  Missed Visit‡                    n/N   24/358    14/358     19/358     67/358     3/358
                                   (%)   (6.7%)    (3.9%)     (5.3%)     (18.7%)    (0.8%)

                                                                                    

  \%                                     333/357   343/357    290/309    222/295    178/187
  Accountability =                       (93.3%)   (96.1%)    (93.9%)    (75.3%)    (95.2%)
  Available for                                                                     
  Analysis ÷                                                                        
  (Enrolled -                                                                       
  Discontinued -                                                                    
  Not yet                                                                           
  eligible)                                                                         

  N = Total eyes                                                                    
  enrolled.                                                                         

  \*               Discontinued =                                                   
                   Exited due to                                                    
                   Technolas laser                                                  
                   retreatment (0                                                   
                   eye) or                                                          
                   non-Technolas                                                    
                   laser                                                            
                   retreatment (18                                                  
                   eyes) or                                                         
                   aborted                                                          
                   procedure (1                                                     
                   eye) or death                                                    
                   (0 eye).                                                         

  †                Loss to                                                          
                   follow-up: Eyes                                                  
                   not examined at                                                  
                   the 24-month                                                     
                   visit, and not                                                   
                   considered                                                       
                   active or                                                        
                   discontinued.                                                    

  ‡                Missed visit:                                                    
                   Eyes not                                                         
                   examined at the                                                  
                   scheduled                                                        
                   visit, but were                                                  
                   then seen at a                                                   
                   subsequent                                                       
                   visit.                                                           
  ---------------- --------------- ----- --------- ---------- ---------- ---------- ----------

> **b. Stability of outcome**
>
> Table 4 presents the results for the stability of the manifest
> refraction spherical equivalent for the consistent cohort (all treated
> eyes examined at 1, 3, and 6 months). The results indicate that at
> least 95% of eyes were within 1.00 D of the previous visit's spherical
> equivalent refraction value during the 1 to 3 months interval. The
> mean of the paired-differences of MRSE reached ≤ \|0.12\| D in the 3
> to 6 months interval. Thus, stability was demonstrated by 6 months
> postoperative.

**Table 4**

**Stability of Manifest Refraction Spherical Equivalent (MRSE)**

**6-Month Consistent Cohort**

  ---------------------- ----------- ----------- ------------ ----------- ----------- ------------
  **Change in**          **Between 1                          **Between 3             
                         and 3                                and 6                   
                         Months**                             Months**                

  **Spherical            **Full      **Treated   **Treated    **Full      **Treated   **Treated
  Refraction**           Cohort**    For**       For**        Cohort**    For**       For**

                                     **Sphere    **Sphere &               **Sphere    **Sphere &
                                     Only**      Cylinder**               Only**      Cylinder**

  Change of **MRSE** by                                                               
  ≤ 1.00 D                                                                            

  n/N (%)                258/267     151/157     107/110      262/269     154/159     108/110
                         (96.6%)     (96.2%)     (97.3%)      (97.4%)     (96.9%)     (98.2%)

  95% CI for %           (94.5%,     (93.2%,     (94.3%,      (95.3%,     (93.5%,     (95.1%,
                         98.8%)      99.1%)      99.9%)       99.5%)      99.9%)      99.9%)

  Change of **MRSE**                                                                  
  (Paired-Differences)                                                                
  in Diopters                                                                         

  Mean                   0.127       0.147       0.098        0.081       0.088       0.070

  SD                     0.483       0.508       0.448        0.408       0.420       0.390

  95% CI for Mean        (0.065,     (0.063,     (0.007,      (0.032,     (0.021,     (-0.000,
                         0.189)      0.231)      0.188)       0.130)      0.155)      0.141)

  **Change in**          **Between 6                          **Between 9             
                         and 9                                and ≥12                 
                         Months**                             Months**                

  **Spherical            **Full      **Treated   **Treated    **Full      **Treated   **Treated
  Refraction**           Cohort**    For**       For**        Cohort**    For**       For**

                                     **Sphere    **Sphere &               **Sphere    **Sphere &
                                     Only**      Cylinder**               Only**      Cylinder**

  Change of **MRSE** by                                                               
  ≤ 1.00 D                                                                            

  n/N (%)                205/210     106/109     99/101       111/112     69/70       42/42
                         (97.6%)     (97.2%)     (98.0%)      (99.1%)     (98.6%)     (100.0%)

  95% CI for %           (95.2%,     (93.3%,     (94.7%,      (96.1%,     (93.8%,     (92.2%,
                         99.9%)      99.9%)      99.9%)       99.9%)      99.9%)      100.0%)

  Change of **MRSE**                                                                  
  (Paired-Differences)                                                                
  in Diopters                                                                         

  Mean                   -0.015      -0.024      -0.005       0.041       0.043       0.039

  SD                     0.388       0.429       0.338        0.352       0.351       0.363

  95% CI for Mean        (-0.074,    (-0.113,    (-0.081,     (-0.031,    (-0.042,    (-0.090,
                         0.044)      0.065)      0.071)       0.113)      0.128)      0.167)

  The 95% confidence                                                                  
  interval was adjusted                                                               
  for the correlation                                                                 
  between eyes.                                                                       

  6-Month Consistent                                                                  
  Cohort: All eyes                                                                    
  examined at 1, 3, and                                                               
  6 months.                                                                           
  ---------------------- ----------- ----------- ------------ ----------- ----------- ------------

c.  **Effectiveness Outcomes\
    **

> Table 5 presents the key effectiveness variables outcomes for all
> treated eyes. Key efficacy outcomes stratified by each 0.50 diopter of
> preoperative MRSE for all treated eyes, eyes treated for spherical
> hyperopia and eyes treated for hyperopic astigmatism are presented in
> Tables 6, 7 and 8 respectively.
>
> It will be noted from Table 6 that the three primary outcomes for
> percent of eyes with 20/40 or better uncorrected visual acuity and
> percent of eyes within ±0.50 D and ±1.00 D of attempted correction are
> all well above the suggested minimum FDA Guidance values for
> hyperopia.
>
> The accuracy of the refractive outcomes and the rate of 20/20 UCVA or
> better are seen to decrease with increasing preoperative MRSE. This is
> due in part to the increased rate of undercorrections with increasing
> baseline MRSE as seen in Table 9. Accuracy within 0.50D of intended
> refractive outcome fell below the target rate of 50% for treatment of
> MRSE greater than +3.50D. Table 10 shows that undercorrections of
> greater than 1.00D occurred at a rate of 12.4% and 13.0% at month 6
> and month 12 respectively and that the average undercorrections were
> 0.31D and 0.37D at these visits.
>
> The accuracy of the refractive outcomes and the rate of 20/20 or
> better UCVA are seen to decrease with increasing preoperative manifest
> refractive cylinder as shown in Tables 11 and 12. The impact of
> preoperative cylinder on UCVA is especially noticeable in the group of
> eyes with 0.50 to 0.75 D cylinder that received spherical treatments.

**Table 5**

**Summary of Key Effectiveness Variables**

**All Treated Eyes**

  --------------- --------------- --------- ----------- ---------- ----------- ---------- ----------- ---------- ----------- ---------- -----------
  **Key                           **1                   **3                    **6                    **9                    **≥ 12     
  Effectiveness                   Month**               Months**               Months**               Months**               Months**   
  Variables**                                                                                                                           

                                            **95%\***              **95%\***              **95%\***              **95%\***              **95%\***

                                  **n/N     **CI**      **n/N      **CI**      **n/N      **CI**      **n/N      **CI**      **n/N      **CI**
                                  (%)**                 (%)**                  (%)**                  (%)**                  (%)**      

  UCVA 20/20 or                   131/258   (44.5,      159/265    (53.6,      143/233    (54.5,      100/168    (51.6,      83/141     (50.7,
  better†                         (50.8%)   57.0)       (60.0%)    66.4)       (61.4%)    68.3)       (59.5%)    67.4)       (58.9%)    67.0)

  UCVA 20/40 or                   243/258   (91.4,      255/265    (94.0,      221/233    (91.6,      161/168    (92.8,      134/141    (91.3,
  better†                         (94.2%)   97.0)       (96.2%)    98.5)       (94.8%)    98.1)       (95.8%)    98.8)       (95.0%)    98.8)

  MRSE‡,                          225/331   (62.6,      222/343    (59.2,      174/290    (53.7,      142/222    (56.7,      109/177    (53.8,
  Attempted vs.                   (68.0%)   73.3)       (64.7%)    70.2)       (60.0%)    66.3)       (64.0%)    71.3)       (61.6%)    69.3)
  Achieved, ±                                                                                                                           
  0.50 D                                                                                                                                

  MRSE‡,                          294/331   (85.2,      314/343    (88.4,      251/290    (81.9,      191/222    (80.8,      151/177    (79.5,
  Attempted vs.                   (88.8%)   92.4)       (91.5%)    94.7)       (86.6%)    91.2)       (86.0%)    91.3)       (85.3%)    91.1)
  Achieved, ±                                                                                                                           
  1.00 D                                                                                                                                

  MRSE‡,                          328/331   (97.8,      340/343    (98.0,      287/290    (97.6,      220/222    (97.6,      175/177    (97.0,
  Attempted vs.                   (99.1%)   99.9)       (99.1%)    99.9)       (99.0%)    99.9)       (99.1%)    99.9)       (98.9%)    99.9)
  Achieved, ±                                                                                                                           
  2.00 D                                                                                                                                

  MRSE‡, from                     180/256   (64.7,      193/265    (67.2,      155/233    (59.9,      120/168    (63.8,      95/141     (58.9,
  Emmetropia, ±                   (70.3%)   75.9)       (72.8%)    78.4)       (66.5%)    73.1)       (71.4%)    79.1)       (67.4%)    75.9)
  0.50 D†                                                                                                                               

  MRSE‡, from                     238/256   (89.7,      246/265    (89.5,      209/233    (85.5,      147/168    (81.9,      120/141    (78.9,
  Emmetropia, ±                   (93.0%)   96.2)       (92.8%)    96.2)       (89.7%)    93.9)       (87.5%)    93.1)       (85.1%)    91.4)
  1.00 D†                                                                                                                               

  MRSE‡, from                     254/256   (97.7,      263/265    (98.0,      232/233    (98.1,      167/168    (97.4,      140/141    (96.9,
  Emmetropia, ±                   (99.2%)   99.9)       (99.2%)    99.9)       (99.6%)    99.9)       (99.4%)    99.9)       (99.3%)    99.9)
  2.00 D†                                                                                                                               

  N = Number of                                                                                                                         
  CRFs received                                                                                                                         
  with                                                                                                                                  
  non-missing                                                                                                                           
  values at each                                                                                                                        
  visit.                                                                                                                                

  \*              The 95%                                                                                                               
                  confidence                                                                                                            
                  interval was                                                                                                          
                  adjusted for                                                                                                          
                  the correlation                                                                                                       
                  between eyes.                                                                                                         

  †               For all eyes                                                                                                          
                  minus those                                                                                                           
                  treated for                                                                                                           
                  monovision.                                                                                                           

  ‡               MRSE = Manifest                                                                                                       
                  Spherical                                                                                                             
                  Equivalent =                                                                                                          
                  Manifest                                                                                                              
                  Sphere + 0.5 ×                                                                                                        
                  Manifest                                                                                                              
                  Cylinder.                                                                                                             

                  One eye                                                                                                               
                  (170-7015-B0)                                                                                                         
                  received a                                                                                                            
                  treatment                                                                                                             
                  (+0.75/+0.75 x                                                                                                        
                  180) outside                                                                                                          
                  the approved                                                                                                          
                  range for                                                                                                             
                  sphere.                                                                                                               
  --------------- --------------- --------- ----------- ---------- ----------- ---------- ----------- ---------- ----------- ---------- -----------

**Table 6**

**Summary of Key Effectiveness Variables at 6 Months (Stable Point)**

**Stratified By Preoperative MRSE**

**All Treated Eyes**

  --------------- --------------- ---------- ---------- ---------- ---------- ---------- ---------- --------- ---------- ---------- -----------
  **Key                           **0.51     **1.01     **1.51     **2.01     **2.51     **3.01     **3.51    **4.01     **4.51     **Total**
  Effectiveness                   to**       to**       to**       to**       to**       to**       to**      to**       to**       
  Variables**                                                                                                                       

                                  **1.00 D** **1.50 D** **2.00 D** **2.50 D** **3.00 D** **3.50 D** **4.00    **4.50 D** **5.00 D** 
                                                                                                    D**                             

                                  **n/N      **n/N      **n/N      **n/N      **n/N      **n/N      **n/N     **n/N      **n/N      **n/N (%)**
                                  (%)**      (%)**      (%)**      (%)**      (%)**      (%)**      (%)**     (%)**      (%)**      

  UCVA 20/20 or                   8/9        33/49      42/62      23/39      22/38      5/15       8/17      2/3        0/1 (0.0%) 143/233
  better†                         (88.9%)    (67.3%)    (67.7%)    (59.0%)    (57.9%)    (33.3%)    (47.1%)   (66.7%)               (61.4%)

  UCVA 20/25 or                   9/9        44/49      51/62      29/39      31/38      8/15       11/17     2/3        0/1 (0.0%) 185/233
  better†                         (100.0%)   (89.8%)    (82.3%)    (74.4%)    (81.6%)    (53.3%)    (64.7%)   (66.7%)               (79.4%)

  UCVA 20/40 or                   9/9        49/49      57/62      36/39      37/38      14/15      15/17     3/3        1/1        221/233
  better†                         (100.0%)   (100.0%)   (91.9%)    (92.3%)    (97.4%)    (93.3%)    (88.2%)   (100.0%)   (100.0%)   (94.8%)

  MRSE\*,                         10/14      54/70      42/71      28/51      22/44      10/18      7/17      1/4        0/1 (0.0%) 174/290
  Attempted vs.                   (71.4%)    (77.1%)    (59.2%)    (54.9%)    (50.0%)    (55.6%)    (41.2%)   (25.0%)               (60.0%)
  Achieved, ±                                                                                                                       
  0.50 D                                                                                                                            

  MRSE\*,                         14/14      66/70      63/71      42/51      36/44      15/18      13/17     2/4        0/1 (0.0%) 251/290
  Attempted vs.                   (100.0%)   (94.3%)    (88.7%)    (82.4%)    (81.8%)    (83.3%)    (76.5%)   (50.0%)               (86.6%)
  Achieved, ±                                                                                                                       
  1.00 D                                                                                                                            

  MRSE\*,                         14/14      70/70      70/71      51/51      43/44      18/18      16/17     4/4        1/1        287/290
  Attempted vs.                   (100.0%)   (100.0%)   (98.6%)    (100.0%)   (97.7%)    (100.0%)   (94.1%)   (100.0%)   (100.0%)   (99.0%)
  Achieved, ±                                                                                                                       
  2.00 D                                                                                                                            

  MRSE\*, from                    8/9        42/49      43/62      23/39      23/38      8/15       8/17      0/3 (0.0%) 0/1 (0.0%) 155/233
  Emmetropia, ±                   (88.9%)    (85.7%)    (69.4%)    (59.0%)    (60.5%)    (53.3%)    (47.1%)                         (66.5%)
  0.50 D†                                                                                                                           

  MRSE\*, from                    9/9        49/49      57/62      34/39      32/38      13/15      14/17     1/3        0/1 (0.0%) 209/233
  Emmetropia, ±                   (100.0%)   (100.0%)   (91.9%)    (87.2%)    (84.2%)    (86.7%)    (82.4%)   (33.3%)               (89.7%)
  1.00 D†                                                                                                                           

  MRSE\*, from                    9/9        49/49      62/62      39/39      38/38      15/15      16/17     3/3        1/1        232/233
  Emmetropia, ±                   (100.0%)   (100.0%)   (100.0%)   (100.0%)   (100.0%)   (100.0%)   (94.1%)   (100.0%)   (100.0%)   (99.6%)
  2.00 D†                                                                                                                           

  N = Number of                                                                                                                     
  CRFs received                                                                                                                     
  with                                                                                                                              
  non-missing                                                                                                                       
  values at each                                                                                                                    
  visit.                                                                                                                            

  \*              MRSE = Manifest                                                                                                   
                  Spherical                                                                                                         
                  Equivalent.                                                                                                       

  †               For all eyes                                                                                                      
                  minus those                                                                                                       
                  treated for                                                                                                       
                  monovision                                                                                                        

                  One eye                                                                                                           
                  (170-7015-B0)                                                                                                     
                  received a                                                                                                        
                  treatment                                                                                                         
                  (+0.75/+0.75 x                                                                                                    
                  180) outside                                                                                                      
                  the approved                                                                                                      
                  range for                                                                                                         
                  sphere.                                                                                                           
  --------------- --------------- ---------- ---------- ---------- ---------- ---------- ---------- --------- ---------- ---------- -----------

**Table 7**

**Summary of Key Effectiveness Variables at 6 Months (Stable Point)**

**Stratified By Preoperative MRSE**

**Eyes Treated for Spherical Hyperopia Only**

  --------------- ------------- ---------- ---------- ---------- ---------- ---------- ---------- ---------- -------- -------- -----------
  **Key                         **0.51     **1.01     **1.51     **2.01     **2.51     **3.01     **3.51     **4.01   **4.51   **Total**
  Effectiveness                 to**       to**       to**       to**       to**       to**       to**       to**     to**     
  Variables**                                                                                                                  

                                **1.00 D** **1.50 D** **2.00 D** **2.50 D** **3.00 D** **3.50 D** **4.00 D** **4.50   **5.00   
                                                                                                             D**      D**      

                                **n/N      **n/N      **n/N      **n/N      **n/N      **n/N      **n/N      **n/N    **n/N    **n/N (%)**
                                (%)**      (%)**      (%)**      (%)**      (%)**      (%)**      (%)**      (%)**    (%)**    

  UCVA 20/20 or                 8/9        20/34      25/35      14/27      11/22      2/8        6/10       NA       NA       86/145
  better†                       (88.9%)    (58.8%)    (71.4%)    (51.9%)    (50.0%)    (25.0%)    (60.0%)                      (59.3%)

  UCVA 20/25 or                 9/9        29/34      29/35      18/27      17/22      3/8        7/10       NA       NA       112/145
  better†                       (100.0%)   (85.3%)    (82.9%)    (66.7%)    (77.3%)    (37.5%)    (70.0%)                      (77.2%)

  UCVA 20/40 or                 9/9        34/34      32/35      25/27      22/22      7/8        10/10      NA       NA       139/145
  better†                       (100.0%)   (100.0%)   (91.4%)    (92.6%)    (100.0%)   (87.5%)    (100.0%)                     (95.9%)

  MRSE\*,                       9/13       35/44      25/43      17/32      13/27      3/9        3/10       NA       NA       105/178
  Attempted vs.                 (69.2%)    (79.5%)    (58.1%)    (53.1%)    (48.1%)    (33.3%)    (30.0%)                      (59.0%)
  Achieved, ±                                                                                                                  
  0.50 D                                                                                                                       

  MRSE\*,                       13/13      42/44      37/43      26/32      21/27      6/9        8/10       NA       NA       153/178
  Attempted vs.                 (100.0%)   (95.5%)    (86.0%)    (81.3%)    (77.8%)    (66.7%)    (80.0%)                      (86.0%)
  Achieved, ±                                                                                                                  
  1.00 D                                                                                                                       

  MRSE\*,                       13/13      44/44      42/43      32/32      27/27      9/9        9/10       NA       NA       176/178
  Attempted vs.                 (100.0%)   (100.0%)   (97.7%)    (100.0%)   (100.0%)   (100.0%)   (90.0%)                      (98.9%)
  Achieved, ±                                                                                                                  
  2.00 D                                                                                                                       

  MRSE\*, from                  8/9        30/34      26/35      14/27      14/22      2/8        4/10       NA       NA       98/145
  Emmetropia, ±                 (88.9%)    (88.2%)    (74.3%)    (51.9%)    (63.6%)    (25.0%)    (40.0%)                      (67.6%)
  0.50 D†                                                                                                                      

  MRSE\*, from                  9/9        34/34      31/35      24/27      17/22      6/8        9/10       NA       NA       130/145
  Emmetropia, ±                 (100.0%)   (100.0%)   (88.6%)    (88.9%)    (77.3%)    (75.0%)    (90.0%)                      (89.7%)
  1.00 D†                                                                                                                      

  MRSE\*, from                  9/9        34/34      35/35      27/27      22/22      8/8        9/10       NA       NA       144/145
  Emmetropia, ±                 (100.0%)   (100.0%)   (100.0%)   (100.0%)   (100.0%)   (100.0%)   (90.0%)                      (99.3%)
  2.00 D†                                                                                                                      

  N = Number of                                                                                                                
  CRFs received                                                                                                                
  with                                                                                                                         
  non-missing                                                                                                                  
  values at each                                                                                                               
  visit.                                                                                                                       

  \*              MRSE =                                                                                                       
                  Manifest                                                                                                     
                  Spherical                                                                                                    
                  Equivalent.                                                                                                  

  †               For all eyes                                                                                                 
                  minus those                                                                                                  
                  treated for                                                                                                  
                  monovision                                                                                                   
  --------------- ------------- ---------- ---------- ---------- ---------- ---------- ---------- ---------- -------- -------- -----------

**Table 8**

**Summary of Key Effectiveness Variables at 6 Months (Stable Point)**

**Stratified By Preoperative MRSE**

**Eyes Treated for Astigmatic Hyperopia**

  --------------- --------------- ---------- ---------- ---------- ---------- ---------- ---------- ---------- ---------- ---------- -----------
  **Key                           **0.51     **1.01     **1.51     **2.01     **2.51     **3.01     **3.51     **4.01     **4.51     **Total**
  Effectiveness                   to**       to**       to**       to**       to**       to**       to**       to**       to**       
  Variables**                                                                                                                        

                                  **1.00 D** **1.50 D** **2.00 D** **2.50 D** **3.00 D** **3.50 D** **4.00 D** **4.50 D** **5.00 D** 

                                  **n/N      **n/N      **n/N      **n/N      **n/N      **n/N      **n/N      **n/N      **n/N      **n/N (%)**
                                  (%)**      (%)**      (%)**      (%)**      (%)**      (%)**      (%)**      (%)**      (%)**      

  UCVA 20/20 or                   NA         13/15      17/27      9/12       11/16      3/7        2/7        2/3        0/1 (0.0%) 57/88
  better†                                    (86.7%)    (63.0%)    (75.0%)    (68.8%)    (42.9%)    (28.6%)    (66.7%)               (64.8%)

  UCVA 20/25 or                   NA         15/15      22/27      11/12      14/16      5/7        4/7        2/3        0/1 (0.0%) 73/88
  better†                                    (100.0%)   (81.5%)    (91.7%)    (87.5%)    (71.4%)    (57.1%)    (66.7%)               (83.0%)

  UCVA 20/40 or                   NA         15/15      25/27      11/12      15/16      7/7        5/7        3/3        1/1        82/88
  better†                                    (100.0%)   (92.6%)    (91.7%)    (93.8%)    (100.0%)   (71.4%)    (100.0%)   (100.0%)   (93.2%)

  MRSE\*,                         1/1        19/26      17/28      11/19      9/17       7/9        4/7        1/4        0/1 (0.0%) 69/112
  Attempted vs.                   (100.0%)   (73.1%)    (60.7%)    (57.9%)    (52.9%)    (77.8%)    (57.1%)    (25.0%)               (61.6%)
  Achieved, ±                                                                                                                        
  0.50 D                                                                                                                             

  MRSE\*,                         1/1        24/26      26/28      16/19      15/17      9/9        5/7        2/4        0/1 (0.0%) 98/112
  Attempted vs.                   (100.0%)   (92.3%)    (92.9%)    (84.2%)    (88.2%)    (100.0%)   (71.4%)    (50.0%)               (87.5%)
  Achieved, ±                                                                                                                        
  1.00 D                                                                                                                             

  MRSE\*,                         1/1        26/26      28/28      19/19      16/17      9/9        7/7        4/4        1/1        111/112
  Attempted vs.                   (100.0%)   (100.0%)   (100.0%)   (100.0%)   (94.1%)    (100.0%)   (100.0%)   (100.0%)   (100.0%)   (99.1%)
  Achieved, ±                                                                                                                        
  2.00 D                                                                                                                             

  MRSE\*, from                    NA         12/15      17/27      9/12       9/16       6/7        4/7        0/3 (0.0%) 0/1 (0.0%) 57/88
  Emmetropia, ±                              (80.0%)    (63.0%)    (75.0%)    (56.3%)    (85.7%)    (57.1%)                          (64.8%)
  0.50 D†                                                                                                                            

  MRSE\*, from                    NA         15/15      26/27      10/12      15/16      7/7        5/7        1/3        0/1 (0.0%) 79/88
  Emmetropia, ±                              (100.0%)   (96.3%)    (83.3%)    (93.8%)    (100.0%)   (71.4%)    (33.3%)               (89.8%)
  1.00 D†                                                                                                                            

  MRSE\*, from                    NA         15/15      27/27      12/12      16/16      7/7        7/7        3/3        1/1        88/88
  Emmetropia, ±                              (100.0%)   (100.0%)   (100.0%)   (100.0%)   (100.0%)   (100.0%)   (100.0%)   (100.0%)   (100.0%)
  2.00 D†                                                                                                                            

  N = Number of                                                                                                                      
  CRFs received                                                                                                                      
  with                                                                                                                               
  non-missing                                                                                                                        
  values at each                                                                                                                     
  visit.                                                                                                                             

  \*              MRSE = Manifest                                                                                                    
                  Spherical                                                                                                          
                  Equivalent.                                                                                                        

  †               For all eyes                                                                                                       
                  minus those                                                                                                        
                  treated for                                                                                                        
                  monovision                                                                                                         

                  One eye                                                                                                            
                  (170-7015-B0)                                                                                                      
                  received a                                                                                                         
                  treatment                                                                                                          
                  (+0.75/+0.75 x                                                                                                     
                  180) outside                                                                                                       
                  the approved                                                                                                       
                  range for                                                                                                          
                  sphere.                                                                                                            
  --------------- --------------- ---------- ---------- ---------- ---------- ---------- ---------- ---------- ---------- ---------- -----------

**Table 9**

**Accuracy of Manifest Spherical Equivalent at 6 Months --- Attempted vs
Achieved**

**Stratified By Preoperative MRSE**

**All Treated Eyes**

  ---------------- -------------- ---------- ---------- --------- ---------- --------- ---------- --------- ---------- ----------
  **Deviation**                   **0.51 to  **1.01 to  **1.51 to **2.01 to  **2.51 to **3.01 to  **3.51 to **4.01 to  **4.51 to
                                  1.00 D‡**  1.50 D**   2.00 D**  2.50 D**   3.00 D**  3.50 D**   4.00 D**  4.50 D**   5.00 D‡**

                                  **n/N      **n/N      **n/N     **n/N      **n/N     **n/N      **n/N     **n/N      **n/N
                                  (%)**      (%)**      (%)**     (%)**      (%)**     (%)**      (%)**     (%)**      (%)**

  ±0.50 D                         10/14      54/70      42/71     28/51      22/44     10/18      7/17      1/4        0/1 (0.0%)
                                  (71.4%)    (77.1%)    (59.2%)   (54.9%)    (50.0%)   (55.6%)    (41.2%)   (25.0%)    

  ±1.00 D                         14/14      66/70      63/71     42/51      36/44     15/18      13/17     2/4        0/1 (0.0%)
                                  (100.0%)   (94.3%)    (88.7%)   (82.4%)    (81.8%)   (83.3%)    (76.5%)   (50.0%)    

  ±2.00 D                         14/14      70/70      70/71     51/51      43/44     18/18      16/17     4/4        1/1
                                  (100.0%)   (100.0%)   (98.6%)   (100.0%)   (97.7%)   (100.0%)   (94.1%)   (100.0%)   (100.0%)

  *Mean (SD)*                     *0.30      *0.19      *0.36     *0.24      *0.52     *0.09      *0.46     *0.56      *1.13 (.)*
                                  (0.28)*    (0.48)*    (0.63)*   (0.70)*    (0.70)*   (0.74)*    (0.95)*   (1.25)*    

  *Range*                         *0.00 to   *-1.13 to  *-1.00 to *-1.25 to  *-0.75 to *-1.00 to  *-0.75 to *-0.75 to  *1.13 to
                                  0.75*      1.38*      2.38*     1.63*      2.75*     1.50*      2.50*     1.75*      1.13*

  Not reported\*                  0          0          0         0          0         0          0         0          0

  Total†                          14         70         71        51         44        18         17        4          1

  Overcorrected \>                0/14       1/70       0/71      2/51       0/44      0/18       0/17      0/4 (0.0%) 0/1 (0.0%)
  1                               (0.0%)     (1.4%)     (0.0%)    (3.9%)     (0.0%)    (0.0%)     (0.0%)               

  Overcorrected \>                0/14       0/70       0/71      0/51       0/44      0/18       0/17      0/4 (0.0%) 0/1 (0.0%)
  2                               (0.0%)     (0.0%)     (0.0%)    (0.0%)     (0.0%)    (0.0%)     (0.0%)               

  Undercorrected                  0/14       3/70       8/71      7/51       8/44      3/18       4/17      2/4        1/1
  \> 1                            (0.0%)     (4.3%)     (11.3%)   (13.7%)    (18.2%)   (16.7%)    (23.5%)   (50.0%)    (100.0%)

  Undercorrected                  0/14       0/70       1/71      0/51       1/44      0/18       1/17      0/4 (0.0%) 0/1 (0.0%)
  \> 2                            (0.0%)     (0.0%)     (1.4%)    (0.0%)     (2.3%)    (0.0%)     (5.9%)               

  *Mean (SD)*                     *0.30      *0.19      *0.36     *0.24      *0.52     *0.09      *0.46     *0.56      *1.13 (.)*
                                  (0.28)*    (0.48)*    (0.63)*   (0.70)*    (0.70)*   (0.74)*    (0.95)*   (1.25)*    

  *Range*                         *0.00 to   *-1.13 to  *-1.00 to *-1.25 to  *-0.75 to *-1.00 to  *-0.75 to *-0.75 to  *1.13 to
                                  0.75*      1.38*      2.38*     1.63*      2.75*     1.50*      2.50*     1.75*      1.13*

  Not reported\*                  0          0          0         0          0         0          0         0          0

  Total†                          14         70         71        51         44        18         17        4          1

  N = Number of                                                                                                        
  CRFs received                                                                                                        
  with non-missing                                                                                                     
  values at each                                                                                                       
  visit.                                                                                                               

  \*               Number of CRFs                                                                                      
                   received with                                                                                       
                   missing values                                                                                      
                   at each visit.                                                                                      

  †                Number of CRFs                                                                                      
                   received at                                                                                         
                   each visit.                                                                                         

  ‡                Lowest                                                                                              
                   Preoperative                                                                                        
                   MRSE = 0.75D.                                                                                       
                   Highest                                                                                             
                   Preoperative                                                                                        
                   MRSE = 4.875D.                                                                                      
  ---------------- -------------- ---------- ---------- --------- ---------- --------- ---------- --------- ---------- ----------

**Table 10**

**Accuracy of Manifest Spherical Equivalent --- Attempted vs Achieved**

**All Treated Eyes**

  ---------------- ------------------ ---------- ---------- ---------- ---------- ----------
  **Deviation**                       **1        **3        **6        **9        **≥ 12
                                      Month**    Months**   Months**   Months**   Months**

                                      **n/N      **n/N      **n/N      **n/N      **n/N
                                      (%)**      (%)**      (%)**      (%)**      (%)**

  ±0.50 D                             225/331    222/343    174/290    142/222    109/177
                                      (68.0%)    (64.7%)    (60.0%)    (64.0%)    (61.6%)

  ±1.00 D                             294/331    314/343    251/290    191/222    151/177
                                      (88.8%)    (91.5%)    (86.6%)    (86.0%)    (85.3%)

  ±2.00 D                             328/331    340/343    287/290    220/222    175/177
                                      (99.1%)    (99.1%)    (99.0%)    (99.1%)    (98.9%)

  *Mean (SD)*                         *0.09      *0.20      *0.31      *0.29      *0.37
                                      (0.67)*    (0.62)*    (0.66)*    (0.65)*    (0.66)*

  *Range*                             *-2.25 to  *-1.50 to  *-1.25 to  *-1.75 to  *-1.38 to
                                      2.63*      2.75*      2.75*      3.13*      3.38*

  Not reported\*                      2          0          0          0          1

  Total†                              333        343        290        222        178

  Overcorrected \>                    13/331     6/343      3/290      5/222      3/177
  1                                   (3.9%)     (1.7%)     (1.0%)     (2.3%)     (1.7%)

  Overcorrected \>                    2/331      0/343      0/290      0/222      0/177
  2                                   (0.6%)     (0.0%)     (0.0%)     (0.0%)     (0.0%)

  Undercorrected                      24/331     23/343     36/290     26/222     23/177
  \> 1                                (7.3%)     (6.7%)     (12.4%)    (11.7%)    (13.0%)

  Undercorrected                      1/331      3/343      3/290      2/222      2/177
  \> 2                                (0.3%)     (0.9%)     (1.0%)     (0.9%)     (1.1%)

  *Mean (SD)*                         *0.09      *0.20      *0.31      *0.29      *0.37
                                      (0.67)*    (0.62)*    (0.66)*    (0.65)*    (0.66)*

  *Range*                             *-2.25 to  *-1.50 to  *-1.25 to  *-1.75 to  *-1.38 to
                                      2.63*      2.75*      2.75*      3.13*      3.38*

  Not reported\*                      2          0          0          0          1

  Total†                              333        343        290        222        178

  N = Number of                                                                   
  CRFs received                                                                   
  with non-missing                                                                
  values at each                                                                  
  visit.                                                                          

  \*               Number of CRFs                                                 
                   received with                                                  
                   missing values at                                              
                   each visit.                                                    

  †                Number of CRFs                                                 
                   received at each                                               
                   visit.                                                         
  ---------------- ------------------ ---------- ---------- ---------- ---------- ----------

**Table 11**

**Summary of Key Effectiveness Variables at 6 Months**

**Stratified By Preoperative MRCYL\***

**Eyes Treated for Spherical Hyperopia Only**

  --------------- ----------------------- ----------- ----------- ----------- -----------
  **Key                                   **0.00 D**  **0.25 D**  **0.50 to** **Total**
  Effectiveness                                                               
  Variables**                                                                 

                                                                  **0.75 D**  

                                          **n/N (%)** **n/N (%)** **n/N (%)** **n/N (%)**

  UCVA 20/20 or                           39/52       30/43       17/50       86/145
  better†                                 (75.0%)     (69.8%)     (34.0%)     (59.3%)

  UCVA 20/40 or                           50/52       43/43       46/50       139/145
  better†                                 (96.2%)     (100.0%)    (92.0%)     (95.9%)

  MRSE, Attempted                         42/65       32/57       31/56       105/178
  vs. Achieved, ±                         (64.6%)     (56.1%)     (55.4%)     (59.0%)
  0.50 D                                                                      

  MRSE, Attempted                         58/65       47/57       48/56       153/178
  vs. Achieved, ±                         (89.2%)     (82.5%)     (85.7%)     (86.0%)
  1.00 D                                                                      

  MRSE, Attempted                         65/65       56/57       55/56       176/178
  vs. Achieved, ±                         (100.0%)    (98.2%)     (98.2%)     (98.9%)
  2.00 D                                                                      

  MRSE, from                              36/52       29/43       33/50       98/145
  Emmetropia, ±                           (69.2%)     (67.4%)     (66.0%)     (67.6%)
  0.50 D†                                                                     

  MRSE, from                              48/52       38/43       44/50       130/145
  Emmetropia, ±                           (92.3%)     (88.4%)     (88.0%)     (89.7%)
  1.00 D†                                                                     

  MRSE, from                              52/52       43/43       49/50       144/145
  Emmetropia, ±                           (100.0%)    (100.0%)    (98.0%)     (99.3%)
  2.00 D†                                                                     

  N = Number of                                                               
  CRFs received                                                               
  with                                                                        
  non-missing                                                                 
  values at each                                                              
  visit.                                                                      

  \*              MRCYL = Manifest                                            
                  Refraction Cylinder                                         
                  Power                                                       

  †               For all eyes minus                                          
                  those treated for                                           
                  monovision                                                  
  --------------- ----------------------- ----------- ----------- ----------- -----------

**Table 12**

**Summary of Key Effectiveness Variables at 6 Months**

**Stratified By Preoperative MRCYL\***

**Eyes Treated for Astigmatic Hyperopia**

  --------------- ----------------------- ----------- ----------- ----------- -----------
  **Key                                   **0.25 to** **1.00 to** **1.75 to** **Total**
  Effectiveness                                                               
  Variables**                                                                 

                                          **0.99 D**  **1.74 D**  **2.00 D**  

                                          **n/N (%)** **n/N (%)** **n/N (%)** **n/N (%)**

  UCVA 20/20 or                           35/48       16/29       6/11        57/88
  better†                                 (72.9%)     (55.2%)     (54.5%)     (64.8%)

  UCVA 20/40 or                           46/48       27/29       9/11        82/88
  better†                                 (95.8%)     (93.1%)     (81.8%)     (93.2%)

  MRSE, Attempted                         39/60       25/41       5/11        69/112
  vs. Achieved, ±                         (65.0%)     (61.0%)     (45.5%)     (61.6%)
  0.50 D                                                                      

  MRSE, Attempted                         53/60       37/41       8/11        98/112
  vs. Achieved, ±                         (88.3%)     (90.2%)     (72.7%)     (87.5%)
  1.00 D                                                                      

  MRSE, Attempted                         60/60       40/41       11/11       111/112
  vs. Achieved, ±                         (100.0%)    (97.6%)     (100.0%)    (99.1%)
  2.00 D                                                                      

  MRSE, from                              33/48       19/29       5/11        57/88
  Emmetropia, ±                           (68.8%)     (65.5%)     (45.5%)     (64.8%)
  0.50 D†                                                                     

  MRSE, from                              43/48       28/29       8/11        79/88
  Emmetropia, ±                           (89.6%)     (96.6%)     (72.7%)     (89.8%)
  1.00 D†                                                                     

  MRSE, from                              48/48       29/29       11/11       88/88
  Emmetropia, ±                           (100.0%)    (100.0%)    (100.0%)    (100.0%)
  2.00 D†                                                                     

  N = Number of                                                               
  CRFs received                                                               
  with                                                                        
  non-missing                                                                 
  values at each                                                              
  visit.                                                                      

  \*              MRCYL = Manifest                                            
                  Refraction Cylinder                                         
                  Power                                                       

  †               For all eyes minus                                          
                  those treated for                                           
                  monovision                                                  

                  One eye (170-7015-B0)                                       
                  received a treatment                                        
                  (+0.75/+0.75 x 180)                                         
                  outside the approved                                        
                  range for sphere                                            
  --------------- ----------------------- ----------- ----------- ----------- -----------

> Table 13 summarizes the increase in astigmatic vector magnitude, or
> induced astigmatism for spherical treatments stratified by the
> attempted level of treatment. This table shows that spherical only
> treatment in eyes with low cylinder (\<1D) at baseline appears to
> induce more astigmatism (which increases with the amount of attempted
> spherical correction). Tables 11 and 12 show the impact of the amount
> of preoperative cylinder on the key efficacy outcomes. These tables
> demonstrate that astigmatic treatment appears to result in better
> effectiveness outcomes.
>
> There was a strong tendency for overcorrection of cylinder, with a
> significant number of eyes with large axis shifts and residual
> astigmatism. The overcorrection of astigmatism averaged 0.22D and
> affected UCVA 20/20 outcome. Spherical corrections induced greater
> amounts of astigmatism than present at baseline

**Table 13**

**Increase in Astigmatic Vector Magnitude (SIRC -- IRC)**

**at the Point of Stability (6 months) Stratified by Attempted Spherical
Correction**

  ------------------------- -------------- -------- -------- -------- -------- -------- --------
  **Statistics**            **Attempted                                                 
                            Spherical                                                   
                            Correction**                                                

                            **0.51 to 1.00 **1.01   **1.51   **2.01   **2.51   **3.01   **3.51
                            D**            to 1.50  to 2.00  to 3.50  to 3.00  to 4.50  to 4.00
                                           D**      D**      D**      D**      D**      D**

  N                         8              35       34       36       31       17       17

  MEAN                      0.34           0.47     0.48     0.51     0.57     0.62     0.71

  MEDIAN                    0.26           0.50     0.46     0.50     0.41     0.50     0.57

  STD                       0.13           0.30     0.36     0.36     0.49     0.56     0.48

  MIN                       0.23           0.00     0.00     0.00     0.00     0.00     0.00

  MAX                       0.50           1.25     1.50     1.69     1.85     2.25     1.83

  IRC = square root of                                                                  
  (preop\*preop +                                                                       
  itt\*itt -                                                                            
  2\*preop\*itt\*cos).                                                                  

  SIRC = square root of                                                                 
  (preop\*preop +                                                                       
  postop\*postop -                                                                      
  2\*preop\*postop\*cos.)                                                               

  Where preop = preop                                                                   
  cylinder, postop = postop                                                             
  cylinder, itt = intended                                                              
  postop cylinder, & cos =                                                              
  cosine of the axis                                                                    
  difference between preop                                                              
  & itt or preop & postop.                                                              

  Since attempted                                                                       
  cylindrical correction =                                                              
  0, intended postop                                                                    
  cylinder = preop                                                                      
  cylinder.                                                                             
  ------------------------- -------------- -------- -------- -------- -------- -------- --------

> Table 14 presents percent reduction of absolute cylinder and achieved
> vs. intended vector magnitude ratio (SIRC/IRC) at the point of
> stability, stratified by diopter of preoperative cylinder. The vector
> magnitude ratio (SIRC/IRC) was 1.33 at 6 months, which was the point
> of refractive stability. Overcorrection of astigmatism was most
> pronounced when treating less than 1.00D cylinder as shown by the mean
> SIRC/IRC ratio of 1.49 in this group. Table 15 shows that the large
> axis shifts (greater than 30°) that result from overcorrections were
> most often associated with less than 1.00D of residual astigmatism.
> Overcorrections of this nature contributed to the low mean percent
> reduction (7.5 ± 87.5%) of absolute cylinder reported in Table 14.
>
> **Table 14**

**Cylinder Correction Effectiveness at the Point of Stability (6 months)
Stratified By Preoperative Cylinder - Astigmatic Hyperopia Eyes** **With
Complete Preoperative and Postoperative Refraction**

  ------------------ -------------- ------------- ---------- --------------- --------------- ---------- ---------------
  **Preoperative**                  **Percent                                **Achieved vs              
                                    Reduction of                             Intended Vector            
                                    Absolute                                 Magnitude Ratio            
                                    Cylinder (Not                            (SIRC/IRC)†**              
                                    Vector)\***                                                         

  **Cylinder**                      **N**         **Mean     **Median        **N**           **Mean     **Median
                                                  (SD)**     (Range)**                       (SD)**     (Range)**

  0.25 to 0.99 D                    60            7.50       16.67 (-300.0   60              1.49       1.20 (0.12 to
                                                  (87.46)    to 100.00)                      (0.83)     4.07)

  1.00 to 1.74 D                    41            51.26      50.00 (-100.0   41              1.19       1.05 (0.31 to
                                                  (40.14)    to 100.00)                      (0.47)     2.99)

  1.75 to 2.00 D                    11            59.58      71.43 (-12.50   11              1.06       0.99 (0.58 to
                                                  (39.92)    to 100.00)                      (0.40)     2.05)

  Total                             112           28.63      45.00 (-300.0   112             1.33       1.04 (0.12 to
                                                  (72.91)    to 100.00)                      (0.70)     4.07)

  \*                 Data with a                                                                        
                     preoperative                                                                       
                     manifest                                                                           
                     cylinder = 0                                                                       
                     were excluded                                                                      
                     from the                                                                           
                     \'Percent                                                                          
                     Reduction of                                                                       
                     Absolute                                                                           
                     Cylinder\'                                                                         
                     calculations                                                                       

  †                  Data with an                                                                       
                     IRC = 0 were                                                                       
                     excluded from                                                                      
                     the                                                                                
                     \'SIRC/IRC\'                                                                       
                     calculation.                                                                       

  Percent Reduction                                                                                     
  of Absolute                                                                                           
  Cylinder =                                                                                            
  Reduction of                                                                                          
  Absolute Cylinder                                                                                     
  ÷ Preop. Cylinder                                                                                     
  × 100. A negative                                                                                     
  value means an                                                                                        
  increase in                                                                                           
  astigmatism.                                                                                          

  IRC = square root                                                                                     
  of (preop ×preop +                                                                                    
  itt ×itt - 2                                                                                          
  ×preop ×itt ×cos).                                                                                    

  SIRC = square root                                                                                    
  of (preop ×preop +                                                                                    
  postop ×postop - 2                                                                                    
  ×preop ×postop                                                                                        
  ×cos.)                                                                                                

  Where preop =                                                                                         
  preop cylinder,                                                                                       
  postop = postop                                                                                       
  cylinder, itt =                                                                                       
  intended postop                                                                                       
  cylinder, & cos =                                                                                     
  cosine of the axis                                                                                    
  difference between                                                                                    
  preop & itt or                                                                                        
  preop & postop.                                                                                       
  ------------------ -------------- ------------- ---------- --------------- --------------- ---------- ---------------

**Table 15**

**Report of the Residual Astigmatic Error at 6 Months**

**Stratified by Preoperative Diopter of Absolute Cylinder**

**Eyes Treated for Astigmatic Hyperopia**

  ------------------ --------------- ------------ --------- -------- --------- --------- -----------
  **Preoperative     **Residual**    **Absolute                                          
  Diopter of**                       Shift in                                            
                                     Manifest                                            
                                     Axis**                                              

  **Absolute         **Manifest      **≤ 5°**     **\> 5°   **\> 10° **\> 15°  **\>      **Total**
  Cylinder**         Cylinder**                   to ≤      to ≤     to ≤      30°**     
                                                  10°**     15°**    30°**               

                     **Magnitude**   **n/N (%)**  **n/N     **n/N    **n/N     **n/N     **n/N (%)**
                                                  (%)**     (%)**    (%)**     (%)**     

  **Preoperative     0.00 to \<0.50  15/60        1/60      0/60     4/60      4/60      24/60
  Manifest Cylinder  D               (25.0%)      (1.7%)    (0.0%)   (6.7%)    (6.7%)    (40.0%)
  0.25 to 0.99 D**                                                                       

  Not reported = 0   0.50 to \<1.00  3/60 (5.0%)  1/60      0/60     4/60      17/60     25/60
                     D                            (1.7%)    (0.0%)   (6.7%)    (28.3%)   (41.7%)

  \# of CRFs with    1.00 to \<2.00  0/60 (0.0%)  1/60      0/60     0/60      10/60     11/60
  non-missing value  D                            (1.7%)    (0.0%)   (0.0%)    (16.7%)   (18.3%)
  = 60                                                                                   

  Total \# of CRFs   2.00 to \<3.00  0/60 (0.0%)  0/60      0/60     0/60      0/60      0/60 (0.0%)
  received = 60      D                            (0.0%)    (0.0%)   (0.0%)    (0.0%)    

                     Total           18/60        3/60      0/60     8/60      31/60     60/60
                                     (30.0%)      (5.0%)    (0.0%)   (13.3%)   (51.7%)   (100.0%)

  **Preoperative     0.00 to \<0.50  10/41        0/41      0/41     0/41      1/41      11/41
  Manifest Cylinder  D               (24.4%)      (0.0%)    (0.0%)   (0.0%)    (2.4%)    (26.8%)
  1.00 to 1.74 D**                                                                       

  Not reported = 0   0.50 to \<1.00  1/41 (2.4%)  4/41      0/41     1/41      17/41     23/41
                     D                            (9.8%)    (0.0%)   (2.4%)    (41.5%)   (56.1%)

  \# of CRFs with    1.00 to \<2.00  0/41 (0.0%)  1/41      0/41     0/41      5/41      6/41
  non-missing value  D                            (2.4%)    (0.0%)   (0.0%)    (12.2%)   (14.6%)
  = 41                                                                                   

  Total \# of CRFs   2.00 to \<3.00  0/41 (0.0%)  0/41      0/41     0/41      1/41      1/41 (2.4%)
  received = 41      D                            (0.0%)    (0.0%)   (0.0%)    (2.4%)    

                     Total           11/41        5/41      0/41     1/41      24/41     41/41
                                     (26.8%)      (12.2%)   (0.0%)   (2.4%)    (58.5%)   (100.0%)

  **Preoperative     0.00 to \<0.50  3/11 (27.3%) 0/11      0/11     1/11      0/11      4/11
  Manifest Cylinder  D                            (0.0%)    (0.0%)   (9.1%)    (0.0%)    (36.4%)
  1.75 to 2.00 D**                                                                       

  Not reported = 0   0.50 to \<1.00  1/11 (9.1%)  0/11      1/11     0/11      2/11      4/11
                     D                            (0.0%)    (9.1%)   (0.0%)    (18.2%)   (36.4%)

  \# of CRFs with    1.00 to \<2.00  0/11 (0.0%)  0/11      0/11     1/11      0/11      1/11 (9.1%)
  non-missing value  D                            (0.0%)    (0.0%)   (9.1%)    (0.0%)    
  = 11                                                                                   

  Total \# of CRFs   2.00 to \<3.00  0/11 (0.0%)  0/11      0/11     0/11      2/11      2/11
  received = 11      D                            (0.0%)    (0.0%)   (0.0%)    (18.2%)   (18.2%)

                     Total           4/11 (36.4%) 0/11      1/11     2/11      4/11      11/11
                                                  (0.0%)    (9.1%)   (18.2%)   (36.4%)   (100.0%)

  Axis shift = 0 for                                                                     
  eyes with a                                                                            
  postoperative                                                                          
  cylinder = 0.                                                                          

  N = \# of CRFs                                                                         
  with non-missing                                                                       
  value.                                                                                 
  ------------------ --------------- ------------ --------- -------- --------- --------- -----------

d.  **Safety Outcomes**

> The key safety variables for all treated eyes are presented in Table
> 16. Key safety outcomes stratified by each 0.50 diopter of
> preoperative MRSE for all treated eyes, eyes treated for spherical
> hyperopia and eyes treated for hyperopic astigmatism are presented in
> Tables 17, 18 and 19 respectively.
>
> Note from Tables 18 and 19 that most reports of Key Safety findings
> occurred in eyes treated for spherical hyperopia only and only 2
> occurred in eyes treated for hyperopic astigmatism. Six out of the 8
> eyes with ≥ 2 lines of BSCVA loss at 6 months had returned to within 1
> line of the preoperative BSCVA at the last available visit. The 2 eyes
> with a sustained 2-line loss had BSCVA of 20/20 and 20/25.
>
> Table 20 provides a listing of all adverse events reported during the
> study at each visit period along with the overall cumulative adverse
> event rate.
>
> Table 21 presents a summary of all complications reported for all
> treated eyes during the course of the study. The most commonly
> reported complication was debris in the interface, reported at least
> once for 15.1% of eyes. Debris continued to be reported for 9 eyes
> (3.1%) at the 6 month visit.
>
> Patient symptoms were graded according to severity as either none,
> mild, moderate, marked, or severe, grade 0 to grade 4 respectively.
> Any symptom for which there is a one-grade increase from baseline is
> considered "worse", while an increase of 2 or more grades is
> considered "significantly worse". Table 22 presents the rate at which
> increased symptoms were reported at the 6-month and 12-month visits.

**Table 16**

**Summary of Key Safety Variables**

**All Treated Eyes**

  ---------------- ---------------------- --------- ---------- ---------- ---------- ----------
  **Key Safety                            **1       **3        **6        **9        **≥ 12
  Variables**                             Month**   Months**   Months**   Months**   Months**

                                          **n/N     **n/N      **n/N      **n/N      **n/N
                                          (%)**     (%)**      (%)**      (%)**      (%)**

  Loss of ≥ 2                             27/328    16/341     8/290      9/220      8/172
  lines BSCVA                             (8.2%)    (4.7%)     (2.8%)     (4.1%)     (4.7%)

  Loss of \> 2                            5/328     5/341      2/290      1/220      0/172
  lines BSCVA                             (1.5%)    (1.5%)     (0.7%)     (0.5%)     (0.0%)

  BSCVA worse than                        2/333     2/341      0/290      1/221      0/177
  20/40                                   (0.6%)    (0.6%)     (0.0%)     (0.5%)     (0.0%)

  BSCVA worse than                        14/310    8/319      3/268      3/204      4/168
  20/25 if 20/20                          (4.5%)    (2.5%)     (1.1%)     (1.5%)     (2.4%)
  or better                                                                          
  preoperatively                                                                     

  Haze ≥ trace                            0/333     0/341      0/290      0/221      0/177
  with loss of                            (0.0%)    (0.0%)     (0.0%)     (0.0%)     (0.0%)
  BSCVA \> 2 lines                                                                   

  Increased                               1/184     2/196      1/178      2/119      0/130
  manifest                                (0.5%)    (1.0%)     (0.6%)     (1.7%)     (0.0%)
  refractive                                                                         
  astigmatism \>                                                                     
  2.0 D\*                                                                            

  Refractive                              2/143     1/147      2/112      0/103      0/44
  astigmatism                             (1.4%)    (0.7%)     (1.8%)     (0.0%)     (0.0%)
  treatment error                                                                    
  \> 2.0 D†                                                                          

  N = Number of                                                                      
  CRFs received                                                                      
  with non-missing                                                                   
  values at each                                                                     
  visit.                                                                             

  \*               For eyes treated for                                              
                   spherical hyperopia                                               
                   only.                                                             

  †                For eyes treated for                                              
                   astigmatic hyperopia.                                             
  ---------------- ---------------------- --------- ---------- ---------- ---------- ----------

**Table 17**

**Summary of Key Safety Variables at 6 Months (Stable Point)**

**Stratified By Preoperative MRSE\***

**All Treated Eyes**

  ---------------- ------------- -------- -------- -------- -------- -------- --------- -------- -------- -------- -----------
  **Key Safety                   **0.51   **1.01   **1.51   **2.01   **2.51   **3.01    **3.51   **4.01   **4.51   **Total**
  Variables**                    to**     to**     to**     to**     to**     to**      to**     to**     to**     

                                 **1.00   **1.50   **2.00   **2.50   **3.00   **3.50    **4.00   **4.50   **5.00   
                                 D**      D**      D**      D**      D**      D**       D**      D**      D**      

                                 **n/N    **n/N    **n/N    **n/N    **n/N    **n/N     **n/N    **n/N    **n/N    **n/N (%)**
                                 (%)**    (%)**    (%)**    (%)**    (%)**    (%)**     (%)**    (%)**    (%)**    

  Loss of ≥ 2                    0/14     0/70     4/71     4/51     0/44     0/18      0/17     0/4      0/1      8/290
  lines BSCVA                    (0.0%)   (0.0%)   (5.6%)   (7.8%)   (0.0%)   (0.0%)    (0.0%)   (0.0%)   (0.0%)   (2.8%)

  Loss of \> 2                   0/14     0/70     2/71     0/51     0/44     0/18      0/17     0/4      0/1      2/290
  lines BSCVA                    (0.0%)   (0.0%)   (2.8%)   (0.0%)   (0.0%)   (0.0%)    (0.0%)   (0.0%)   (0.0%)   (0.7%)

  BSCVA worse than               0/14     0/70     0/71     0/51     0/44     0/18      0/17     0/4      0/1      0/290
  20/40                          (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)    (0.0%)   (0.0%)   (0.0%)   (0.0%)

  BSCVA worse than               0/14     0/68     2/69     1/48     0/38     0/15      0/13     0/3      NA       3/268
  20/25 if 20/20                 (0.0%)   (0.0%)   (2.9%)   (2.1%)   (0.0%)   (0.0%)    (0.0%)   (0.0%)            (1.1%)
  or better                                                                                                        
  preoperatively                                                                                                   

  Haze ≥ trace                   0/14     0/70     0/71     0/51     0/44     0/18      0/17     0/4      0/1      0/290
  with loss of                   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)    (0.0%)   (0.0%)   (0.0%)   (0.0%)
  BSCVA \> 2 lines                                                                                                 

  Increased                      0/13     0/44     0/43     0/32     0/27     1/9       0/10     NA       NA       1/178
  manifest                       (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (11.1%)   (0.0%)                     (0.6%)
  refractive                                                                                                       
  astigmatism \>                                                                                                   
  2.0 D§                                                                                                           

  Refractive                     0/1      0/26     1/28     1/19     0/17     0/9       0/7      0/4      0/1      2/112
  astigmatism                    (0.0%)   (0.0%)   (3.6%)   (5.3%)   (0.0%)   (0.0%)    (0.0%)   (0.0%)   (0.0%)   (1.8%)
  treatment error                                                                                                  
  \> 2.0 D†                                                                                                        

  N = Number of                                                                                                    
  CRFs received                                                                                                    
  with non-missing                                                                                                 
  values at each                                                                                                   
  visit.                                                                                                           

  \*               MRSE =                                                                                          
                   Manifest                                                                                        
                   Spherical                                                                                       
                   Equivalent.                                                                                     

  §                For eyes                                                                                        
                   treated for                                                                                     
                   spherical                                                                                       
                   hyperopia                                                                                       
                   only.                                                                                           

  †                For eyes                                                                                        
                   treated for                                                                                     
                   astigmatic                                                                                      
                   hyperopia.                                                                                      
  ---------------- ------------- -------- -------- -------- -------- -------- --------- -------- -------- -------- -----------

**Table 18**

**Summary of Key Safety Variables at 6 Months (Stable Point)**

**Stratified By Preoperative MRSE\***

**Eyes Treated for Spherical Hyperopia Only**

  ---------------- ------------- -------- -------- -------- --------- -------- --------- -------- -------- -------- -----------
  **Key Safety                   **0.51   **1.01   **1.51   **2.01    **2.51   **3.01    **3.51   **4.01   **4.51   **Total**
  Variables**                    to**     to**     to**     to**      to**     to**      to**     to**     to**     

                                 **1.00   **1.50   **2.00   **2.50    **3.00   **3.50    **4.00   **4.50   **5.00   
                                 D**      D**      D**      D**       D**      D**       D**      D**      D**      

                                 **n/N    **n/N    **n/N    **n/N     **n/N    **n/N     **n/N    **n/N    **n/N    **n/N (%)**
                                 (%)**    (%)**    (%)**    (%)**     (%)**    (%)**     (%)**    (%)**    (%)**    

  Loss of ≥ 2                    0/13     0/44     4/43     4/32      0/27     0/9       0/10     NA       NA       8/178
  lines BSCVA                    (0.0%)   (0.0%)   (9.3%)   (12.5%)   (0.0%)   (0.0%)    (0.0%)                     (4.5%)

  Loss of \> 2                   0/13     0/44     2/43     0/32      0/27     0/9       0/10     NA       NA       2/178
  lines BSCVA                    (0.0%)   (0.0%)   (4.7%)   (0.0%)    (0.0%)   (0.0%)    (0.0%)                     (1.1%)

  BSCVA worse than               0/13     0/44     0/43     0/32      0/27     0/9       0/10     NA       NA       0/178
  20/40                          (0.0%)   (0.0%)   (0.0%)   (0.0%)    (0.0%)   (0.0%)    (0.0%)                     (0.0%)

  BSCVA worse than               0/13     0/42     2/42     1/29      0/23     0/7       0/8      NA       NA       3/164
  20/25 if 20/20                 (0.0%)   (0.0%)   (4.8%)   (3.4%)    (0.0%)   (0.0%)    (0.0%)                     (1.8%)
  or better                                                                                                         
  preoperatively                                                                                                    

  Haze ≥ trace                   0/13     0/44     0/43     0/32      0/27     0/9       0/10     NA       NA       0/178
  with loss of                   (0.0%)   (0.0%)   (0.0%)   (0.0%)    (0.0%)   (0.0%)    (0.0%)                     (0.0%)
  BSCVA \> 2 lines                                                                                                  

  Increased                      0/13     0/44     0/43     0/32      0/27     1/9       0/10     NA       NA       1/178
  manifest                       (0.0%)   (0.0%)   (0.0%)   (0.0%)    (0.0%)   (11.1%)   (0.0%)                     (0.6%)
  refractive                                                                                                        
  astigmatism \>                                                                                                    
  2.0 D                                                                                                             

  N = Number of                                                                                                     
  CRFs received                                                                                                     
  with non-missing                                                                                                  
  values at each                                                                                                    
  visit.                                                                                                            

  \*               MRSE =                                                                                           
                   Manifest                                                                                         
                   Spherical                                                                                        
                   Equivalent.                                                                                      
  ---------------- ------------- -------- -------- -------- --------- -------- --------- -------- -------- -------- -----------

**Table 19**

**Summary of Key Safety Variables at 6 Months (Stable Point)**

**Stratified By Preoperative MRSE\***

**Eyes Treated for Astigmatic Hyperopia**

  ---------------- ------------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -----------
  **Key                          **0.51   **1.01   **1.51   **2.01   **2.51   **3.01   **3.51   **4.01   **4.51   **Total**
  Effectiveness                  to**     to**     to**     to**     to**     to**     to**     to**     to**     
  Variables**                                                                                                     

                                 **1.00   **1.50   **2.00   **2.50   **3.00   **3.50   **4.00   **4.50   **5.00   
                                 D**      D**      D**      D**      D**      D**      D**      D**      D**      

                                 **n/N    **n/N    **n/N    **n/N    **n/N    **n/N    **n/N    **n/N    **n/N    **n/N (%)**
                                 (%)**    (%)**    (%)**    (%)**    (%)**    (%)**    (%)**    (%)**    (%)**    

  Loss of ≥ 2                    0/1      0/26     0/28     0/19     0/17     0/9      0/7      0/4      0/1      0/112
  lines BSCVA                    (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)

  Loss of \> 2                   0/1      0/26     0/28     0/19     0/17     0/9      0/7      0/4      0/1      0/112
  lines BSCVA                    (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)

  BSCVA worse than               0/1      0/26     0/28     0/19     0/17     0/9      0/7      0/4      0/1      0/112
  20/40                          (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)

  BSCVA worse than               0/1      0/26     0/27     0/19     0/15     0/8      0/5      0/3      NA       0/104
  20/25 if 20/20                 (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)            (0.0%)
  or better                                                                                                       
  preoperatively                                                                                                  

  Haze ≥ trace                   0/1      0/26     0/28     0/19     0/17     0/9      0/7      0/4      0/1      0/112
  with loss of                   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)
  BSCVA \> 2 lines                                                                                                

  Increased                      NA       NA       NA       NA       NA       NA       NA       NA       NA       NA
  manifest                                                                                                        
  refractive                                                                                                      
  astigmatism \>                                                                                                  
  2.0 D                                                                                                           

  Refractive                     0/1      0/26     1/28     1/19     0/17     0/9      0/7      0/4      0/1      2/112
  astigmatism                    (0.0%)   (0.0%)   (3.6%)   (5.3%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (0.0%)   (1.8%)
  treatment error                                                                                                 
  \> 2.0 D†                                                                                                       

  N = Number of                                                                                                   
  CRFs received                                                                                                   
  with non-missing                                                                                                
  values at each                                                                                                  
  visit.                                                                                                          

  \*               MRSE =                                                                                         
                   Manifest                                                                                       
                   Spherical                                                                                      
                   Equivalent.                                                                                    

  †                For eyes                                                                                       
                   treated for                                                                                    
                   astigmatic                                                                                     
                   hyperopia.                                                                                     
  ---------------- ------------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -----------

**Table 20**

**Adverse Events Summary --- All Treated Eyes**

  -------------- ----------------- -------- -------- --------- ---------- ---------- ---------- ---------- ----------------
  **All Reported                   **1      **7      **1       **3        **6        **9        **≥12      **Cumulative**
  Adverse                          Day**    Day**    Month**   Months**   Months**   Months**   Months**   
  Events**                                                                                                 

                                   **n/N    **n/N    **n/N     **n/N      **n/N      **n/N      **n/N      **n/N (%)**
                                   (%)**    (%)**    (%)**     (%)**      (%)**      (%)**      (%)**      

  Angioplasty                      0/355    0/339    0/333     0/343      0/290      0/222      2/178      2/358 (0.6%)
                                   (0.0%)   (0.0%)   (0.0%)    (0.0%)     (0.0%)     (0.0%)     (1.1%)     

  Anterior                         1/355    1/339    2/333     4/343      3/290      3/222      1/178      4/358 (1.1%)
  membrane                         (0.3%)   (0.3%)   (0.6%)    (1.2%)     (1.0%)     (1.4%)     (0.6%)     
  dystrophy                                                                                                

  Corneal edema                    0/355    0/339    1/333     0/343      0/290      0/222      1/178      2/358 (0.6%)
  (flap) at \> 1                   (0.0%)   (0.0%)   (0.3%)    (0.0%)     (0.0%)     (0.0%)     (0.6%)     
  month                                                                                                    

  Debris in                        1/355    0/339    0/333     0/343      0/290      0/222      0/178      1/358 (0.3%)
  interface                        (0.3%)   (0.0%)   (0.0%)    (0.0%)     (0.0%)     (0.0%)     (0.0%)     

  Decrease in                      0/355    0/339    0/333     0/343      2/290      1/222      0/178      3/358 (0.8%)
  BSCVA of \> 2                    (0.0%)   (0.0%)   (0.0%)    (0.0%)     (0.7%)     (0.5%)     (0.0%)     
  lines not due                                                                                            
  to irregular                                                                                             
  astigmatism                                                                                              

  Edema                            0/355    0/339    1/333     0/343      0/290      0/222      0/178      1/358 (0.3%)
                                   (0.0%)   (0.0%)   (0.3%)    (0.0%)     (0.0%)     (0.0%)     (0.0%)     

  Epithelial                       0/355    1/339    2/333     0/343      0/290      0/222      0/178      3/358 (0.8%)
  ingrowth                         (0.0%)   (0.3%)   (0.6%)    (0.0%)     (0.0%)     (0.0%)     (0.0%)     

  Folds in flap                    2/355    1/339    0/333     0/343      0/290      0/222      0/178      3/358 (0.8%)
                                   (0.6%)   (0.3%)   (0.0%)    (0.0%)     (0.0%)     (0.0%)     (0.0%)     

  Heart attack                     0/355    0/339    1/333     0/343      0/290      0/222      0/178      2/358 (0.6%)
                                   (0.0%)   (0.0%)   (0.3%)    (0.0%)     (0.0%)     (0.0%)     (0.0%)     

  Lamellar                         6/355    0/339    0/333     0/343      0/290      0/222      0/178      6/358 (1.7%)
  keratitis                        (1.7%)   (0.0%)   (0.0%)    (0.0%)     (0.0%)     (0.0%)     (0.0%)     

  Mini-stroke                      0/355    0/339    0/333     0/343      0/290      0/222      2/178      2/358 (0.6%)
                                   (0.0%)   (0.0%)   (0.0%)    (0.0%)     (0.0%)     (0.0%)     (1.1%)     

  Procedure                        0/355    0/339    0/333     0/343      0/290      0/222      0/178      1/358 (0.3%)
  aborted                          (0.0%)   (0.0%)   (0.0%)    (0.0%)     (0.0%)     (0.0%)     (0.0%)     

  Secondary                        3/355    2/339    3/333     0/343      0/290      0/222      0/178      7/358 (2.0%)
  surgical                         (0.8%)   (0.6%)   (0.9%)    (0.0%)     (0.0%)     (0.0%)     (0.0%)     
  intervention                                                                                             
  other than                                                                                               
  excimer laser                                                                                            
  treatment                                                                                                

  Not reported\*                   0        0        0         0          0          0          0          0

  Total†                           355      339      333       343        290        222        178        358

  1 PROCEDURE                                                                                              
  ABORTED was                                                                                              
  reported at                                                                                              
  day of                                                                                                   
  surgery. 1                                                                                               
  LAMELLAR                                                                                                 
  KERATITIS was                                                                                            
  reported at an                                                                                           
  interim visit                                                                                            
  between 1 day                                                                                            
  to 7 day                                                                                                 
  postop.                                                                                                  

  1 ANTERIOR                                                                                               
  MEMBRANE                                                                                                 
  DYSTROPHY was                                                                                            
  reported at an                                                                                           
  interim visit                                                                                            
  between 7 days                                                                                           
  to 1 month                                                                                               
  postop.                                                                                                  

  2 ANTERIOR                                                                                               
  MEMBRANE                                                                                                 
  DYSTROPHY, & 1                                                                                           
  HEART ATTACK                                                                                             
  were reported                                                                                            
  at an interim                                                                                            
  visit between                                                                                            
  1 to 3 months                                                                                            
  postop.                                                                                                  

  N = Number of                                                                                            
  CRFs received                                                                                            
  with                                                                                                     
  non-missing                                                                                              
  values at each                                                                                           
  visit.                                                                                                   

  \*             Number of CRFs                                                                            
                 received with                                                                             
                 missing values at                                                                         
                 each visit.                                                                               

  †              Number of CRFs                                                                            
                 received at each                                                                          
                 visit.                                                                                    
  -------------- ----------------- -------- -------- --------- ---------- ---------- ---------- ---------- ----------------

**Table 21**

**Complications Summary --- All Treated Eyes**

  ------------------ -------- -------- --------- ---------- ---------- ---------- ---------- ----------------
  **All Reported     **1      **7      **1       **3        **6        **9        **≥ 12     **Cumulative**
  Complications**    Day**    Day**    Month**   Months**   Months**   Months**   Months**   

                     **n/N    **n/N    **n/N     **n/N      **n/N      **n/N      **n/N      **n/N (%)**
                     (%)**    (%)**    (%)**     (%)**      (%)**      (%)**      (%)**      

  Allergies          0/355    1/339    0/333     0/343      0/290      0/222      0/178      1/358 (0.3%)
                     (0.0%)   (0.3%)   (0.0%)    (0.0%)     (0.0%)     (0.0%)     (0.0%)     

  Bells palsy        0/355    0/339    0/333     0/343      0/290      1/222      1/178      1/358 (0.3%)
                     (0.0%)   (0.0%)   (0.0%)    (0.0%)     (0.0%)     (0.5%)     (0.6%)     

  Blepharitis        0/355    0/339    1/333     2/343      4/290      4/222      3/178      7/358 (2.0%)
                     (0.0%)   (0.0%)   (0.3%)    (0.6%)     (1.4%)     (1.8%)     (1.7%)     

  Blurry vision      0/355    0/339    1/333     0/343      0/290      0/222      0/178      1/358 (0.3%)
                     (0.0%)   (0.0%)   (0.3%)    (0.0%)     (0.0%)     (0.0%)     (0.0%)     

  Bowmans wrinkle    0/355    0/339    0/333     0/343      1/290      1/222      1/178      1/358 (0.3%)
                     (0.0%)   (0.0%)   (0.0%)    (0.0%)     (0.3%)     (0.5%)     (0.6%)     

  Chalazion          0/355    0/339    0/333     0/343      0/290      1/222      0/178      1/358 (0.3%)
                     (0.0%)   (0.0%)   (0.0%)    (0.0%)     (0.0%)     (0.5%)     (0.0%)     

  Conjunctival       0/355    0/339    1/333     0/343      0/290      0/222      0/178      1/358 (0.3%)
  injection          (0.0%)   (0.0%)   (0.3%)    (0.0%)     (0.0%)     (0.0%)     (0.0%)     

  Conjunctivitis     0/355    1/339    2/333     2/343      4/290      2/222      4/178      8/358 (2.2%)
                     (0.0%)   (0.3%)   (0.6%)    (0.6%)     (1.4%)     (0.9%)     (2.2%)     

  Corneal abrasion   3/355    0/339    0/333     0/343      0/290      0/222      0/178      3/358 (0.8%)
                     (0.8%)   (0.0%)   (0.0%)    (0.0%)     (0.0%)     (0.0%)     (0.0%)     

  Corneal edema at ≤ 0/355    20/339   4/333     0/343      0/290      0/222      0/178      24/358 (6.7%)
  1 month            (0.0%)   (5.9%)   (1.2%)    (0.0%)     (0.0%)     (0.0%)     (0.0%)     

  Debris in          29/355   26/339   26/333    18/343     9/290      9/222      8/178      54/358 (15.1%)
  interface          (8.2%)   (7.7%)   (7.8%)    (5.2%)     (3.1%)     (4.1%)     (4.5%)     

  Double vision      0/355    0/339    2/333     0/343      1/290      0/222      0/178      3/358 (0.8%)
                     (0.0%)   (0.0%)   (0.6%)    (0.0%)     (0.3%)     (0.0%)     (0.0%)     

  Edema              0/355    1/339    0/333     0/343      0/290      1/222      0/178      3/358 (0.8%)
                     (0.0%)   (0.3%)   (0.0%)    (0.0%)     (0.0%)     (0.5%)     (0.0%)     

  Epiretinal         0/355    0/339    0/333     0/343      0/290      1/222      1/178      1/358 (0.3%)
  membrane           (0.0%)   (0.0%)   (0.0%)    (0.0%)     (0.0%)     (0.5%)     (0.6%)     

  Epithelial defect  6/355    2/339    2/333     1/343      0/290      0/222      0/178      8/358 (2.2%)
                     (1.7%)   (0.6%)   (0.6%)    (0.3%)     (0.0%)     (0.0%)     (0.0%)     

  Epithelial         0/355    0/339    0/333     3/343      2/290      1/222      1/178      5/358 (1.4%)
  ingrowth           (0.0%)   (0.0%)   (0.0%)    (0.9%)     (0.7%)     (0.5%)     (0.6%)     

  Epithelium in the  1/355    0/339    0/333     0/343      0/290      0/222      0/178      1/358 (0.3%)
  interface          (0.3%)   (0.0%)   (0.0%)    (0.0%)     (0.0%)     (0.0%)     (0.0%)     

  Epithelium in the  1/355    1/339    1/333     1/343      4/290      1/222      0/178      5/358 (1.4%)
  interface with     (0.3%)   (0.3%)   (0.3%)    (0.3%)     (1.4%)     (0.5%)     (0.0%)     
  loss ≤ 2 lines of                                                                          
  BSCVA                                                                                      

  Erosion            1/355    1/339    0/333     0/343      0/290      0/222      0/178      1/358 (0.3%)
                     (0.3%)   (0.3%)   (0.0%)    (0.0%)     (0.0%)     (0.0%)     (0.0%)     

  Folds in flap      0/355    0/339    0/333     2/343      0/290      0/222      2/178      3/358 (0.8%)
                     (0.0%)   (0.0%)   (0.0%)    (0.6%)     (0.0%)     (0.0%)     (1.1%)     

  Ghost images       0/355    0/339    2/333     0/343      0/290      0/222      0/178      2/358 (0.6%)
                     (0.0%)   (0.0%)   (0.6%)    (0.0%)     (0.0%)     (0.0%)     (0.0%)     

  Guttata            2/355    0/339    2/333     0/343      1/290      1/222      0/178      5/358 (1.4%)
                     (0.6%)   (0.0%)   (0.6%)    (0.0%)     (0.3%)     (0.5%)     (0.0%)     

  Interface          0/355    0/339    0/333     1/343      0/290      0/222      0/178      1/358 (0.3%)
  disruption         (0.0%)   (0.0%)   (0.0%)    (0.3%)     (0.0%)     (0.0%)     (0.0%)     

  Itching            0/355    0/339    0/333     0/343      2/290      0/222      0/178      2/358 (0.6%)
                     (0.0%)   (0.0%)   (0.0%)    (0.0%)     (0.7%)     (0.0%)     (0.0%)     

  Keratitis          0/355    0/339    0/333     0/343      1/290      0/222      0/178      1/358 (0.3%)
                     (0.0%)   (0.0%)   (0.0%)    (0.0%)     (0.3%)     (0.0%)     (0.0%)     

  Meibomitis         0/355    0/339    0/333     0/343      2/290      2/222      0/178      2/358 (0.6%)
                     (0.0%)   (0.0%)   (0.0%)    (0.0%)     (0.7%)     (0.9%)     (0.0%)     

  Opacity,           0/355    0/339    0/333     0/343      5/290      2/222      5/178      10/358 (2.8%)
  crystalline lens   (0.0%)   (0.0%)   (0.0%)    (0.0%)     (1.7%)     (0.9%)     (2.8%)     

  Pain \> 7 days     0/355    0/339    0/333     0/343      1/290      0/222      0/178      1/358 (0.3%)
                     (0.0%)   (0.0%)   (0.0%)    (0.0%)     (0.3%)     (0.0%)     (0.0%)     

  Papillae           0/355    0/339    3/333     2/343      0/290      0/222      0/178      4/358 (1.1%)
                     (0.0%)   (0.0%)   (0.9%)    (0.6%)     (0.0%)     (0.0%)     (0.0%)     

  Partial flap       1/355    0/339    0/333     0/343      0/290      0/222      0/178      1/358 (0.3%)
                     (0.3%)   (0.0%)   (0.0%)    (0.0%)     (0.0%)     (0.0%)     (0.0%)     

  Not reported\*     0        0        0         0          0          0          0          0

  Total†             355      339      333       343        290        222        178        358
  ------------------ -------- -------- --------- ---------- ---------- ---------- ---------- ----------------

**Table 21**

**Complications Summary --- All Treated Eyes *(Continued)***

  ----------------- ----------------- -------- -------- --------- ---------- ---------- ---------- ---------- ----------------
  **All Reported                      **1      **7      **1       **3        **6        **9        **≥ 12     **Cumulative**
  Complications**                     Day**    Day**    Month**   Months**   Months**   Months**   Months**   

                                      **n/N    **n/N    **n/N     **n/N      **n/N      **n/N      **n/N      **n/N (%)**
                                      (%)**    (%)**    (%)**     (%)**      (%)**      (%)**      (%)**      

  Peripheral                          6/355    0/339    1/333     0/343      1/290      0/222      0/178      8/358 (2.2%)
  corneal                             (1.7%)   (0.0%)   (0.3%)    (0.0%)     (0.3%)     (0.0%)     (0.0%)     
  epithelial defect                                                                                           
  (on the flap)                                                                                               

  Posterior                           0/355    0/339    0/333     1/343      0/290      0/222      0/178      1/358 (0.3%)
  vitreous                            (0.0%)   (0.0%)   (0.0%)    (0.3%)     (0.0%)     (0.0%)     (0.0%)     
  detachment                                                                                                  

  Pterygium                           0/355    0/339    0/333     0/343      0/290      1/222      0/178      1/358 (0.3%)
                                      (0.0%)   (0.0%)   (0.0%)    (0.0%)     (0.0%)     (0.5%)     (0.0%)     

  Punctal stenosis                    0/355    0/339    0/333     0/343      0/290      2/222      0/178      2/358 (0.6%)
                                      (0.0%)   (0.0%)   (0.0%)    (0.0%)     (0.0%)     (0.9%)     (0.0%)     

  Redness                             0/355    0/339    0/333     0/343      0/290      1/222      0/178      1/358 (0.3%)
                                      (0.0%)   (0.0%)   (0.0%)    (0.0%)     (0.0%)     (0.5%)     (0.0%)     

  Sebaceous cyst                      0/355    0/339    0/333     0/343      0/290      1/222      0/178      1/358 (0.3%)
                                      (0.0%)   (0.0%)   (0.0%)    (0.0%)     (0.0%)     (0.5%)     (0.0%)     

  Subconjunctival                     1/355    1/339    1/333     0/343      0/290      0/222      0/178      2/358 (0.6%)
  hemorrhage                          (0.3%)   (0.3%)   (0.3%)    (0.0%)     (0.0%)     (0.0%)     (0.0%)     

  Subepithelial                       0/355    0/339    0/333     0/343      1/290      0/222      0/178      1/358 (0.3%)
  opacity                             (0.0%)   (0.0%)   (0.0%)    (0.0%)     (0.3%)     (0.0%)     (0.0%)     

  Trichiasis                          0/355    0/339    0/333     0/343      1/290      1/222      0/178      2/358 (0.6%)
                                      (0.0%)   (0.0%)   (0.0%)    (0.0%)     (0.3%)     (0.5%)     (0.0%)     

  Vitreal traction                    0/355    0/339    1/333     0/343      0/290      0/222      0/178      2/358 (0.6%)
                                      (0.0%)   (0.0%)   (0.3%)    (0.0%)     (0.0%)     (0.0%)     (0.0%)     

  Vitreous                            0/355    0/339    0/333     0/343      0/290      1/222      0/178      1/358 (0.3%)
  detachment                          (0.0%)   (0.0%)   (0.0%)    (0.0%)     (0.0%)     (0.5%)     (0.0%)     

  Not reported\*                      0        0        0         0          0          0          0          0

  Total†                              355      339      333       343        290        222        178        358

  2 DEBRIS IN                                                                                                 
  INTERFACE, 1                                                                                                
  EDEMA, & 1                                                                                                  
  PERIPHERAL                                                                                                  
  CORNEAL                                                                                                     
  EPITHELIAL DEFECT                                                                                           
  (ON THE FLAP)                                                                                               
  were reported at                                                                                            
  an interim visit                                                                                            
  between 7 days to                                                                                           
  1 month postop.                                                                                             

  1 BLEPHARITIS, 1                                                                                            
  EPITHELIAL                                                                                                  
  INGROWTH, & 1                                                                                               
  VITREAL TRACTION                                                                                            
  were reported at                                                                                            
  an interim visit                                                                                            
  between 1 to 3                                                                                              
  months postop.                                                                                              

  1 DEBRIS IN                                                                                                 
  INTERFACE, & 1                                                                                              
  EPITHELIAL                                                                                                  
  INGROWTH were                                                                                               
  reported at an                                                                                              
  interim visit                                                                                               
  between 3 to 6                                                                                              
  months postop. 1                                                                                            
  DEBRIS IN                                                                                                   
  INTERFACE was                                                                                               
  reported at an                                                                                              
  interim visit                                                                                               
  between 6 to 9                                                                                              
  months postop.                                                                                              

  N = Number of                                                                                               
  CRFs received                                                                                               
  with non-missing                                                                                            
  values at each                                                                                              
  visit.                                                                                                      

  \*                Number of CRFs                                                                            
                    received with                                                                             
                    missing values at                                                                         
                    each visit.                                                                               

  †                 Number of CRFs                                                                            
                    received at each                                                                          
                    visit.                                                                                    
  ----------------- ----------------- -------- -------- --------- ---------- ---------- ---------- ---------- ----------------

![](media/image1.wmf)

**e. Patient Symptoms**

> The rate of symptoms reported as none, mild, and moderate to severe
> preoperatively and at 6 months are reported in Table 23. A statistical
> comparison of the rates of clinically significant symptoms (moderate
> to severe) at the preoperative versus the 6 month visit demonstrated
> that 6 months after treatment patients had significantly lower
> occurrences of headaches (3.0% vs. 14.3%, p\<0.0001), excessive
> tearing (2.6% vs. 7.5%, p\<.00029) and difficulties with night driving
> (11.3% vs. 20.8%, p\<0.003). The occurrence rate for the symptoms
> dryness (22.6% vs. 10.5%, p\<0.0001), gritty feeling (6.8% vs 2.6%),
> fluctuation of vision (14.7% vs. 5.7%, p-value = 0.0005), and
> variations of vision in dim light (18.1% vs. 27.9%, p\<0.0032) were
> higher at the 6 month visit than at the preoperative visit.
>
> Changes in patient symptoms from preoperative to 1 month, 6 months and
> ≥ 12 months are presented in Tables 24 through 26. The proportion of
> eyes that rated each symptom better at 6 months than at baseline
> versus the proportion of eyes that rated each symptom worse at 6
> months than at baseline were compared statistically. This analysis
> showed that the proportion of eyes that improved was significantly
> greater than the proportion of eyes that got worse for the symptoms
> headaches (p \<0.0001), excessive tearing (p\<0.0001), and
> difficulties with night driving (p\<0.0001). The analysis also
> demonstrated that the proportion of eyes with symptoms rated as worse
> was significantly greater than the proportion of eyes that had the
> symptom rated better for dryness (p\<0.0001), gritty feeling
> (p\<.0024), double vision (p\<0.0135), ghost images (p\<0.0005),
> fluctuations of vision (p\<0.0001), variations of vision in normal
> light (p\<0.0001) and variations of vision in dim light (p\<0.0002).
>
> Treatment of higher amounts of hyperopia resulted in a lower rate of
> accuracy in the refractive outcome (see Section IX.F.2.c). An analysis
> of the impact of treatment accuracy on symptoms showed that the rate
> of "worse" and "significantly worse" symptoms increased as the
> magnitude of the treatment inaccuracy increased as seen in Table 27.
> The effect reached statistical significance (p\<0.05) for headaches
> and for variation of vision in bright and dim light.
>
> Induced astigmatism was associated with spherical treatments and the
> efficacy of spherical treatments was reduced relative to astigmatic
> treatments for eyes with low amounts of astigmatism (see Section
> IX.F.2.c). The symptom data for spherical versus astigmatic
> treatments, shown in Table 28, do not follow these same trends.

**Table 23**

**Patient Symptoms at Preop & 6 Months**

**All Treated Eyes**

  ----------------- ------------ ----------- ------------ ----------- ------------ ----------
  **Patient         **None**                 **Mild**                 **Moderate   
  Symptoms**                                                          to Severe**  

                    **% (n/N)**              **% (n/N)**              **% (n/N)**  

                    **Preop.**   **6         **Preop.**   **6         **Preop.**   **6
                                 Months**                 Months**                 Months**

  Light sensitivity 47.7%        44.2%       29.1%        36.1%       23.1%        19.7%
                    (167/350)    (121/274)   (102/350)    (99/274)    (81/350)     (54/274)

  Headaches         68.6%        84.7%       19.7%        12.4%       11.7%        2.9%
                    (240/350)    (232/274)   (69/350)     (34/274)    (41/350)     (8/274)

  Pain              89.4%        92.0%       8.3%         6.9%        2.3% (8/350) 1.1%
                    (313/350)    (252/274)   (29/350)     (19/274)                 (3/274)

  Redness           75.4%        71.9%       18.6%        20.4%       6.0%         7.7%
                    (264/350)    (197/274)   (65/350)     (56/274)    (21/350)     (21/274)

  Dryness           60.6%        34.3%       29.4%        43.8%       10.0%        21.9%
                    (212/350)    (94/274)    (103/350)    (120/274)   (35/350)     (60/274)

  Tearing           76.3%        88.3%       16.3%        9.1%        7.4%         2.6%
                    (267/350)    (242/274)   (57/350)     (25/274)    (26/350)     (7/274)

  Burning           77.1%        77.0%       19.4%        20.8%       3.4%         2.2%
                    (270/350)    (211/274)   (68/350)     (57/274)    (12/350)     (6/274)

  Gritty feeling    77.4%        67.9%       19.7%        25.5%       2.9%         6.6%
                    (271/350)    (186/274)   (69/350)     (70/274)    (10/350)     (18/274)

  Glare             59.1%        49.6%       28.9%        37.6%       12.0%        12.8%
                    (207/350)    (136/274)   (101/350)    (103/274)   (42/350)     (35/274)

  Halos             82.0%        73.7%       11.1%        16.4%       6.9%         9.9%
                    (287/350)    (202/274)   (39/350)     (45/274)    (24/350)     (27/274)

  Blurred vision    57.1%        43.8%       21.4%        37.6%       21.4%        18.6%
                    (200/350)    (120/274)   (75/350)     (103/274)   (75/350)     (51/274)

  Double vision     91.7%        82.5%       5.1%         12.0%       3.1%         5.5%
                    (321/350)    (226/274)   (18/350)     (33/274)    (11/350)     (15/274)

  Ghost images      92.3%        78.8%       4.9%         16.8%       2.9%         4.4%
                    (323/350)    (216/274)   (17/350)     (46/274)    (10/350)     (12/274)

  Fluctuations of   70.0%        38.3%       24.3%        47.1%       5.7%         14.6%
  vision            (245/350)    (105/274)   (85/350)     (129/274)   (20/350)     (40/274)

  Variation of      58.3%        57.7%       30.0%        32.5%       11.7%        9.9%
  vision in bright  (204/350)    (158/274)   (105/350)    (89/274)    (41/350)     (27/274)
  light                                                                            

  Variation of      78.9%        63.5%       16.0%        29.2%       5.1%         7.3%
  vision in normal  (276/350)    (174/274)   (56/350)     (80/274)    (18/350)     (20/274)
  light                                                                            

  Variation of      51.4%        35.8%       30.3%        36.5%       18.3%        27.7%
  vision in dim     (180/350)    (98/274)    (106/350)    (100/274)   (64/350)     (76/274)
  light                                                                            

  Night driving     43.4%        59.5%       38.0%        29.6%       18.6%        10.9%
  vision            (152/350)    (163/274)   (133/350)    (81/274)    (65/350)     (30/274)

  N = Number of                                                                    
  Self-evaluation                                                                  
  Forms received                                                                   
  with non-missing                                                                 
  values at each                                                                   
  visit.                                                                           

  At 6 months, the                                                                 
  symptoms graded                                                                  
  as moderate or                                                                   
  worse that were                                                                  
  reported at an                                                                   
  incidence level                                                                  
  of more than 1%                                                                  
  higher than the                                                                  
  baseline                                                                         
  incidence level                                                                  
  were redness,                                                                    
  dryness, gritty                                                                  
  feeling, halos,                                                                  
  double vision,                                                                   
  ghost images,                                                                    
  fluctuations of                                                                  
  vision, variation                                                                
  of vision in                                                                     
  normal light, and                                                                
  variation of                                                                     
  vision in dim                                                                    
  light.                                                                           

  15 'other'                                                                       
  symptoms were                                                                    
  reported                                                                         
  preoperative and                                                                 
  8 'other'                                                                        
  symptoms were                                                                    
  reported at 6                                                                    
  Months                                                                           
  ----------------- ------------ ----------- ------------ ----------- ------------ ----------

![](media/image2.wmf)

![](media/image3.wmf)

![](media/image4.wmf)

**Table 27**

**Impact of Treatment Accuracy**

**On Patient Symptom Changes from Preoperative to 6 Months**

![](media/image5.wmf)

**Table 28**

**Impact of Treatment Type (Astigmatic vs. Spherical)**

**On Patient Symptom Changes from Preoperative to 6 Months**

![](media/image6.wmf)

**f. Retreatment**

> Eighteen (18) eyes were discontinued following their 6 month visits
> due to retreatment with other than the TECHNOLAS 217A laser. The
> retreatments ranged from low hyperopia (due to undercorrection) to low
> myopia (due to overcorrection). In the absence of data from the
> clinical trial, no recommendations can be made regarding the safety
> and effectiveness of LASIK retreatment, however, caution should be
> taken to assure refractive stability before performing additional
> procedures.
>
> **g. Factors Associated with Outcomes**
>
> The primary effectiveness outcomes (UCVA 20/40 or better, MRSE
> deviation from attempted correction within ± 0.50 D and ±1.00 D) were
> analysed by baseline characteristics (surgical eye, age, gender,
> preoperative MRSE, and preoperative MRCYL), and study site. These
> analyses show the following:
>
> 1\) For UCVA of 20/40 or better at 3 and 6 months postoperative, there
> are no significant differences between the primary (first) eye and the
> fellow eye results.
>
> 2\) The success rates are consistent among the different age groups
> with the exception of the 30 to \<40 age group whose success rate of
> MRSE deviation from attempted correction with ±1.00 D was lower at 6
> months.

3)  The success rates are consistent between males and females.

4)  The success rates are consistent between sites with one exception of
    the primary effectiveness variables. At 3 months, one site had a
    relatively lower success rate of MRSE deviation from attempted
    correction within ±0.50D for treated primary eyes compared to rates
    at other sites.

5)  The success rates of UCVA 20/40 or better are consistent among the
    different preoperative spherical equivalent groups. For the success
    rates of MRSE deviation from attempted correction within ±0.50D and
    ±1.00D, there are significant differences which suggest the
    effectiveness of the treatment diminishes at the high end of the
    treatment range. Accuracy within ±0.50D decreases from 83% to 47% in
    the spherical treatment group at the extremes of the attempted
    corrections.

6)  The success rates are consistent among the different preoperative
    manifest cylinder groups with the exception of the 6-month outcome
    of UCVA 20/40 or better, eyes with a preoperative manifest cylinder
    of 2.00D to 2.99D. This group had a relatively lower success rate
    than the other groups.

7)  Accuracy of refractive outcomes and the proportion of eyes that
    achieve UCVA 20/20 decrease with increasing preoperative manifest
    refractive cylinder and with MRSE.

> **h. Patient Satisfaction**
>
> Responses provided by the study subjects at 3 and 6 months to three
> questions regarding their experiences with the laser surgery are
> provided in Table 29. These three questions related to: 1) the
> perceived overall quality of vision following surgery; 2) the
> subject's willingness to have the surgery again if he/she could make
> the choice over; and 3) the subject's overall satisfaction with the
> results of the surgical procedure.
>
> Over 98% of patients (by eye) indicated that there was improvement in
> the quality of vision after excimer laser. Less than 3% of patients
> indicated that they were dissatisfied with the results of their
> excimer laser treatment.

**Table 29**

**Self-Evaluation at 3 and 6 Months**

**Overall Quality of Vision, Choose Again, & Satisfaction**

**All Treated Eyes**

  ------------------- ---------------- --------------- ------------- ------------- --------------
  **Slef-Evaluation                    **Response**    **Overall**   **Spherical   **Astigmatic
  Questions**                                                        Hyperopia**   Hyperopia**

                                                       **% (n/N)**   **% (n/N)**   **% (n/N)**

  **3 Months**                                                                     

  Overall Quality of                   No Improvement  1.2% (4/331)  1.1% (2/184)  1.4% (2/147)
  Vision                                                                           

  after Excimer Laser                  Slight          3.6% (12/331) 3.3% (6/184)  4.1% (6/147)
                                       Improvement                                 

                                       Moderate        9.4% (31/331) 10.3%         8.2% (12/147)
                                       Improvement                   (19/184)      

                                       Marked          32.3%         28.8%         36.7% (54/147)
                                       Improvement     (107/331)     (53/184)      

                                       Extreme         53.5%         56.5%         49.7% (73/147)
                                       Improvement     (177/331)     (104/184)     

                                       Not reported\*  6             6             0

                                       Total†          337           190           147

  Choose Excimer                       No              2.1% (7/332)  1.6% (3/187)  2.8% (4/145)
  Again?                                                                           

                                       Unsure          6.6% (22/332) 6.4% (12/187) 6.9% (10/145)

                                       Yes             91.3%         92.0%         90.3%
                                                       (303/332)     (172/187)     (131/145)

                                       Not reported\*  5             3             2

                                       Total†          337           190           147

  How Satisfied with                   Very Satisfied  70.8%         71.7%         69.7%
  the                                                  (233/329)     (132/184)     (101/145)

  Excimer Laser                        Moderately      21.6%         22.3%         20.7% (30/145)
  Results?                             Satisfied       (71/329)      (41/184)      

                                       Neutral         5.5% (18/329) 4.9% (9/184)  6.2% (9/145)

                                       Dissatisfied    2.1% (7/329)  1.1% (2/184)  3.4% (5/145)

                                       Very            0.0% (0/329)  0.0% (0/184)  0.0% (0/145)
                                       Dissatisfied                                

                                       Not reported\*  8             6             2

                                       Total†          337           190           147

  **6 Months**                                                                     

  Overall Quality of                   No Improvement  1.1% (3/269)  0.6% (1/157)  1.8% (2/112)
  Vision                                                                           

  after Excimer Laser                  Slight          4.5% (12/269) 3.2% (5/157)  6.3% (7/112)
                                       Improvement                                 

                                       Moderate        10.0%         10.2%         9.8% (11/112)
                                       Improvement     (27/269)      (16/157)      

                                       Marked          34.2%         33.1%         35.7% (40/112)
                                       Improvement     (92/269)      (52/157)      

                                       Extreme         50.2%         52.9%         46.4% (52/112)
                                       Improvement     (135/269)     (83/157)      

                                       Not reported\*  5             5             0

                                       Total†          274           162           112

  Choose Excimer                       No              1.9% (5/263)  0.6% (1/154)  3.7% (4/109)
  Again?                                                                           

                                       Unsure          8.7% (23/263) 7.8% (12/154) 10.1% (11/109)

                                       Yes             89.4%         91.6%         86.2% (94/109)
                                                       (235/263)     (141/154)     

                                       Not reported\*  11            8             3

                                       Total†          274           162           112

  How Satisfied with                   Very Satisfied  71.7%         76.8%         64.5% (71/110)
  the                                                  (190/265)     (119/155)     

  Excimer Laser                        Moderately      20.8%         18.7%         23.6% (26/110)
  Results?                             Satisfied       (55/265)      (29/155)      

                                       Neutral         4.9% (13/265) 3.2% (5/155)  7.3% (8/110)

                                       Dissatisfied    2.3% (6/265)  1.3% (2/155)  3.6% (4/110)

                                       Very            0.4% (1/265)  0.0% (0/155)  0.9% (1/110)
                                       Dissatisfied                                

                                       Not reported\*  9             7             2

                                       Total†          274           162           112

  N = Number of CRFs                                                               
  received with                                                                    
  non-missing values                                                               
  at each visit.                                                                   

  \*                  Number of CRFs                                               
                      received with                                                
                      missing values                                               
                      at each visit.                                               

  †                   Number of CRFs                                               
                      received at each                                             
                      visit.                                                       
  ------------------- ---------------- --------------- ------------- ------------- --------------

> **i. Device Failures and Replacements**
>
> There were a total of 4 cases out of 358 procedures with problems
> during surgery. Of these, 3 were epithelial defects and one was due to
> an aborted LASIK procedure secondary to a loss of suction before the
> microkeratome pass.

### [CONCLUSIONS DRAWN FROM THE STUDIES]{.underline}

> The data in this application provides reasonable assurance that the
> device is safe and effective when used in accordance with the
> directions for use.

### [PANEL RECOMMENDATION]{.underline}

> In accordance with the provisions of section 515(c)(2) of the act as
> amended by the Safe Medical Devices Act of 1990, this PMA was not
> referred to the Ophthalmic Device Panel, and FDA advisory committee,
> for review and recommendation because the information in the PMA
> substantially duplicates information previously reviewed by this
> panel.

### [CDRH DECISION]{.underline}

> CDRH issued an approval order on February 25, 2003. The applicant's
> manufacturing facility was inspected on February 11-14, 2002 and was
> found to be in compliance with the medical device Quality System
> Regulation.

### [APPROVAL SPECIFICATIONS]{.underline}

Directions for Use: See Device Labeling.

Hazards to health from use of the device: See Indications,
Contraindications, Warnings, Precautions and Adverse Events in the
labeling.

Post-approval requirements and restrictions: See Approval Order