**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

\(909\) 971-5100

#### 

####  Date(s) of Panel Recommendation: None

#### 

####  PMA Number: P990027/S2

####  Date of Good Manufacturing Practice

**Inspection:** February 11-14, 2002

#### 

####  Date of Notice of Approval May 17, 2002

to Applicant:

The Bausch & Lomb TECHNOLAS^®^217A Excimer Laser System was approved on
February 23, 2000 under PMA P990027/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 or without ≤ -3.00
D astigmatism. The sponsor submitted the current supplement to further
expand the indication statement. The updated clinical data to support
this expanded 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/S2 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
> laser in-situ keratomileusis (LASIK) treatments:

-   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 \<-3.00 D;

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-   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; and,

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-   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-3 .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 -- myopia or astigmatism.
>
> **The TECHNOLAS^®^217A Excimer Laser System consists of the following
> components:**

+-----------+----------------------------------------------------------+
| ####      | The laser unit consists of the laser head (discharge     |
|           | system), which contains the optical resonator and a      |
| #### L    | discharge chamber, which is filled with a premix of      |
| aser Unit | 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

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

> Alternative methods of correcting nearsightedness (myopia) include:
> glasses, contact lenses, photorefractive keratectomy (PRK), incisional
> refractive keratotomy (RK), and lamellar refractive keratotomy.

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

> Over 500 TECHNOLAS^®^217A 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, 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-5 .unnumbered}

Potential adverse reactions associated with LASIK include: loss of best
spectacle corrected visual acuity, worsening of patient complaints such
as 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.

Please refer to Tables 10 and 11 for a summary of adverse events
observed in this clinical trial.

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 the study was to demonstrate the safety and
> effectiveness of the Bausch & Lomb TECHNOLAS^®^217A Excimer Laser
> System for the correction of moderate to high myopia from \>-7.00 to
> -10.99 diopters with astigmatism less than 3.00 diopters (in minus
> cylinder form) or MRSE -12.00 D when used as part of the LASIK
> surgical procedure.

B.  **Study Design**

> The core study for this submission was a prospective, open-label,
> non-randomized, multi-center clinical evaluation conducted at eight
> clinical sites. The study protocol originally allowed for the
> enrollment of eyes with myopia from -1.00 to -12.00 diopters. However,
> during the conduct of this study, the Bausch & Lomb TECHNOLAS 217A
> Excimer Laser System was approved for the treatment of up to -7.00
> diopters of myopia and less than 3.00 diopters of astigmatism based on
> the results of a separate investigational study. Therefore, for the
> purposes of determining safety and effectiveness for treatment of
> moderate to high myopia (greater than -7 diopters), a sub-group of
> eyes from this study with myopia greater than -7.00 diopters was used
> to support safety and effectiveness.
>
> **C Inclusion and Exclusion Criteria**
>
> In order to be enrolled in the study, patients needed to meet these
> conditions: have the required amount of myopia and astigmatism; have a
> stable refraction for the past year; discontinue use of contact lenses
> prior to surgery; have normal, healthy eyes 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; and provide
> written informed consent.
>
> 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; residual, recurrent, active ocular or
> uncontrolled eyelid disease, or any corneal abnormality (specifically,
> recurrent corneal erosion, severe basement membrane disease);
> ophthalmoscopic signs of progressive or unstable myopia or
> keratoconus; required ablation is deeper than 250 microns from the
> corneal endothelium; unstable corneal mires on central keratotomy
> readings; blind in the fellow eye; previous ocular surgery; history of
> herpes zoster or herpes simplex keratitis, diabetes, autoimmune
> disease, connective tissue disease, or clinically significant atopic
> syndrome; taking chronic systemic corticosteroid or other
> immunosuppressive therapy; immunocompromised; pregnant, lactating, or
> of child-bearing potential and not practicing a medically approved
> form of birth control; sensitivity to planned evaluation medications;
> simultaneous participation in any 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 wk,
>
> 1 month, 3 months and 6 months postoperatively.
>
> Subjects were permitted to have second eyes (fellow eyes) treated on
> the same day as 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. To qualify
> for retreatment, eyes must have had residual myopia
> [\>]{.underline}0.50D and/or residual astigmatism
> [\>]{.underline}0.50D and/or uncorrected visual acuity worse than
> 20/40.
>
> 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,
> pupil size, 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 April 1999 to April 2000. The database
> for this PMA supplement reflected data collected through March 15,
> 2001. A total of 308 eyes were treated at eight sites.

2.  **Demographics\
    **

> The demographics of this study are typical for a contemporary
> refractive surgery trial performed in the U.S. The cohort consists
> primarily of Caucasians.

**Table 1: Demographics - All Treated Eyes**

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

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

  NUMBER OF EYES &                     80 Eyes of                    228 Eyes of                   308 Eyes of  
  SUBJECTS                             65 Enrolled                   152 Enrolled                  188 Enrolled 
                                       Subjects                      Subjects                      Subjects     

  GENDER                                                                                                        

                     Male              27           33.8%            89           39.0%            116          37.7%

                     Female            53           66.3%            139          61.0%            192          62.3%

  RACE                                                                                                          

                     White             75           93.8%            216          94.7%            291          94.5%

                     Black             2            2.5%             2            0.9%             4            1.3%

                     Asian             3            3.8%             5            2.2%             8            2.6%

                     Other             0            0.0%             5            2.2%             5            1.6%

  SURGICAL EYE                                                                                                  

                     Right             38           47.5%            110          48.2%            148          48.1%

                     Left              42           52.5%            118          51.8%            160          51.9%

  AGE (in years)                                                                                                

                     Mean              37.3 ( 9.7)                   38.6 ( 8.9)                   38.2 ( 9.1)  

                     Minimum, Maximum  19.5, 56.8                    20.2, 60.6                    19.5, 60.6   
  ------------------ ----------------- ------------ ---------------- ------------ ---------------- ------------ ----------------

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):                                  
                                    0.92 (0.77),                                  
                                    Range:                                        
                                    0.00\* to                                     
                                    3.50**                                        

  **Mean (SD): 8.65                 **0.00 to    **1.00 to  **2.00 to  **3.00 to  
  (1.17)**                          0.99 D**     1.99 D**   2.99 D**   3.99 D**   

  **Range: 7.25 to                  **n/N (%)**  **n/N      **n/N      **n/N      **n/N (%)**
  12.25**                                        (%)**      (%)**      (%)**      

  7.01 to 7.99 D                    59/308       25/308     9/308      1/308      94/308 (30.5)
                                    (19.2)       (8.1)      (2.9)      (0.3)      

  8.00 to 8.99 D                    60/308       30/308     12/308     1/308      103/308
                                    (19.5)       (9.7)      (3.9)      (0.3)      (33.4)

  9.00 to 9.99 D                    34/308       22/308     7/308      3/308      66/308 (21.4)
                                    (11.0)       (7.1)      (2.3)      (1.0)      

  10.00 to 10.99 D                  11/308 (3.6) 6/308      4/308      0/308      21/308 (6.8)
                                                 (1.9)      (1.3)      (0.0)      

  11.00 to 11.99 D                  7/308 (2.3)  8/308      3/308      2/308      20/308 (6.5)
                                                 (2.6)      (1.0)      (0.6)      

  12.00 D                           4/308 (1.3)  0/308      0/308      0/308      4/308 (1.3)
                                                 (0.0)      (0.0)      (0.0)      

  Total                             175/308      91/308     35/308     7/308      308/308
                                    (56.8)       (29.5)     (11.4)     (2.3)      (100.0)

  N = Total number                                                                
  of eyes treated                                                                 
  for astigmatic                                                                  
  myopia.                                                                         

  1 eye                                                                           
  (-8.50-2.50x165)                                                                
  was reported with                                                               
  an aborted                                                                      
  procedure.                                                                      

  5 of 5 eyes that                                                                
  were treated for                                                                
  mono-vision had an                                                              
  astigmatic myopia                                                               
  treatment.                                                                      

  \*                 Eyes with a                                                  
                     preoperative                                                 
                     manifiest                                                    
                     cylinder = 0                                                 
                     were treated                                                 
                     based on their                                               
                     preoperatve                                                  
                     cycloplegic                                                  
                     cylinder.                                                    
  ------------------ -------------- ------------ ---------- ---------- ---------- -------------

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

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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 Month**   **3 Months**  **6 Months**

  Available for                          n/N    294/308       292/308       263/308
  Analysis                               (%)    (95.5%)       (94.8%)       (85.4%)

                                                                            

  Discontinued\*                         n/N    1/308 (0.3%)  1/308 (0.3%)  8/308 (2.6%)
                                         (%)                                

                                                                            

  Active                                 n/N    0/308 (0.0%)  0/308 (0.0%)  21/308 (6.8%)
                                         (%)                                

  (Not yet                                                                  
  eligible for the                                                          
  interval)                                                                 

                                                                            

  Lost to                                n/N    0/308 (0.0%)  2/308 (0.6%)  16/308 (5.2%)
  Follow-up†                             (%)                                

                                                                            

  Missed Visit‡                          n/N    13/308 (4.2%) 13/308 (4.2%) 0/308 (0.0%)
                                         (%)                                

                                                                            

  \%                                            294/307       292/307       263/279
  Accountability =                              (95.8%)       (95.1%)       (94.3%)
  Available for                                                             
  Analysis                                                                  
  (Enrolled --                                                              
  Discontinued -                                                            
  Not yet                                                                   
  eligible)                                                                 

  N = Total eyes                                                            
  enrolled                                                                  

  \*               Discontinued = Exited                                    
                   due to Technolas                                         
                   laser retreatment (7                                     
                   eyes) or                                                 
                   non-Technolas laser                                      
                   retreatment (0 eye)                                      
                   or aborted procedure                                     
                   (1 eye) or death (0                                      
                   eye).                                                    

  †                Loss to follow-up:                                       
                   Eyes not examined at                                     
                   the 6 month visit,                                       
                   and not considered                                       
                   active or                                                
                   discontinued. 16                                         
                   cases of                                                 
                   lost-to-follow-up                                        
                   were 170-9013-A0,                                        
                   170-9013-B0,                                             
                   170-9025-A0,                                             
                   170-9026-B0,                                             
                   316-9030-A0,                                             
                   316-9030-B0,                                             
                   351-9012-A0,                                             
                   407-9060-A0,                                             
                   407-9060-B0,                                             
                   407-9085-A0,                                             
                   407-9085-B0,                                             
                   409-9009-A0,                                             
                   409-9026-A0,                                             
                   409-9026-B0,                                             
                   420-9048-A0, and                                         
                   420-9048-B0.                                             

  ‡                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). Table 4 demonstrates that over
> 95% of the overall cohort were within 1.00 D by 6 months. The mean of
> the differences was 0.037 D between 3 and 6 months with a standard
> deviation of 0.485.

**Table 4**

**Stability of Manifest Refraction Sphere (MRSE)**

**Consistent Cohort (N=248)**

  ---------------------- -------------- ----------- ----------- ------------ ----------- ----------- ------------
  **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 (%)                               226/248     54/59       172/189      236/248     54/59       182/189
                                        (91.1%)     (91.5%)     (91.0%)      (95.2%)     (91.5%)     (96.3%)

  95% CI for %                          (87.4%,     (83.3%,     (87.1%,      (91.9%,     (83.7%,     (93.3%,
                                        94.9%)      99.7%)      95.0%)       98.4%)      99.3%)      99.3%)

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

  Mean                                  -0.193      -0.129      -0.212       -0.037      -0.042      -0.035

  SD                                    0.619       0.696       0.595        0.485       0.511       0.477

  95% CI for Mean                       (-0.287,    (-0.336,    (-0.312,     (-0.110,    (-0.200,    (-0.111,
                                        -0.098)     0.078)      -0.113)      0.036)      0.115)      0.041)

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

                         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 at 1, 3 and 6 months. Key efficacy outcomes stratified by
> each diopter of preoperative MRSE for all treated eyes are presented
> in Table 6.

**Table 5**

**Summary of Key Effectiveness Variables**

**All Treated Eyes**

  --------------- ------------------- --------- ----------- ---------- ----------- ---------- -----------
  **Key Safety &                      **1                   **3                    **6        
  Effectiveness                       Month**               Months**               Months**   
  Variables**                                                                                 

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

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

  UCVA 20/20 or                       145/290   (43.5,      138/288    (41.3,      138/259    (46.0,
  better†                             (50.0%)   56.5)       (47.9%)    54.5)       (53.3%)    60.5)

  UCVA 20/40 or                       261/290   (86.3,      260/288    (86.1,      234/259    (86.4,
  better†                             (90.0%)   93.7)       (90.3%)    94.4)       (90.3%)    94.3)

  MRSE‡,                              177/294   (54.1,      174/292    (53.1,      161/263    (54.7,
  Attempted vs.                       (60.2%)   66.3)       (59.6%)    66.1)       (61.2%)    67.7)
  Achieved, 0.50                                                                              
  D                                                                                           

  MRSE‡,                              245/294   (78.5,      232/292    (74.2,      216/263    (76.9,
  Attempted vs.                       (83.3%)   88.1)       (79.5%)    84.7)       (82.1%)    87.4)
  Achieved, 1.00                                                                              
  D                                                                                           

  MRSE‡,                              287/294   (95.7,      282/292    (94.1,      253/263    (93.7,
  Attempted vs.                       (97.6%)   99.6)       (96.6%)    99.0)       (96.2%)    98.7)
  Achieved, 2.00                                                                              
  D                                                                                           

  MRSE‡, from                         182/290   (56.9,      176/288    (54.6,      159/259    (54.8,
  Emmetropia,                         (62.8%)   68.6)       (61.1%)    67.6)       (61.4%)    68.0)
  0.50 D†                                                                                     

  MRSE‡, from                         245/290   (79.8,      223/288    (72.0,      211/259    (75.9,
  Emmetropia,                         (84.5%)   89.2)       (77.4%)    82.9)       (81.5%)    87.0)
  1.00 D†                                                                                     

  MRSE‡, from                         283/290   (95.6,      277/288    (93.6,      249/259    (93.6,
  Emmetropia,                         (97.6%)   99.6)       (96.2%)    98.7)       (96.1%)    98.7)
  2.00 D†                                                                                     

  Vector                              157/219   (65.4,      140/219    (56.8,      126/198    (56.2,
  Deviation, 0.5                      (71.7%)   78.0)       (63.9%)    71.0)       (63.6%)    71.1)
  D§                                                                                          

  Vector                              183/219   (78.3,      176/219    (74.7,      155/198    (71.8,
  Deviation, 1.0                      (83.6%)   88.9)       (80.4%)    86.0)       (78.3%)    84.7)
  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.                                                                   

  §               For eyes treated                                                            
                  for astigmatic                                                              
                  myopia.                                                                     
  --------------- ------------------- --------- ----------- ---------- ----------- ---------- -----------

**Table 6**

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

**Stratified By Preoperative MRSE\***

**All Treated Eyes**

  --------------- --------------- --------- --------- --------- --------- --------- ----------- -----------
  **Key                           **7.00    **8.00    **9.00    **10.00   **11.00               **Total**
  Effectiveness                   to**      to**      to**      to**      to**                  
  Variables**                                                                                   

                                  **7.99    **8.99    **9.99    **10.99   **11.99   **12.00**   
                                  D**       D**       D**       D**       D**                   

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

  UCVA 20/20 or                   24/44     51/94     40/68     12/26     6/18      5/9 (55.6%) 138/259
  better†                         (54.5%)   (54.3%)   (58.8%)   (46.2%)   (33.3%)               (53.3%)

  UCVA 20/40 or                   40/44     87/94     62/68     22/26     15/18     8/9 (88.9%) 234/259
  better†                         (90.9%)   (92.6%)   (91.2%)   (84.6%)   (83.3%)               (90.3%)

  MRSE, Attempted                 30/44     52/94     45/68     19/29     9/18      6/10        161/263
  vs. Achieved,                   (68.2%)   (55.3%)   (66.2%)   (65.5%)   (50.0%)   (60.0%)     (61.2%)
  0.50 D                                                                                        

  MRSE, Attempted                 38/44     79/94     57/68     24/29     10/18     8/10        216/263
  vs. Achieved,                   (86.4%)   (84.0%)   (83.8%)   (82.8%)   (55.6%)   (80.0%)     (82.1%)
  1.00 D                                                                                        

  MRSE, Attempted                 43/44     93/94     64/68     27/29     16/18     10/10       253/263
  vs. Achieved,                   (97.7%)   (98.9%)   (94.1%)   (93.1%)   (88.9%)   (100.0%)    (96.2%)
  2.00 D                                                                                        

  MRSE, from                      29/44     53/94     47/68     18/26     7/18      5/9 (55.6%) 159/259
  Emmetropia,                     (65.9%)   (56.4%)   (69.1%)   (69.2%)   (38.9%)               (61.4%)
  0.50 D†                                                                                       

  MRSE, from                      38/44     79/94     58/68     20/26     8/18      8/9 (88.9%) 211/259
  Emmetropia,                     (86.4%)   (84.0%)   (85.3%)   (76.9%)   (44.4%)               (81.5%)
  1.00 D†                                                                                       

  MRSE, from                      43/44     93/94     64/68     24/26     16/18     9/9         249/259
  Emmetropia,                     (97.7%)   (98.9%)   (94.1%)   (92.3%)   (88.9%)   (100.0%)    (96.1%)
  2.00 D†                                                                                       

  Vector                          16/25     49/76     32/49     14/23     11/17     4/8 (50.0%) 126/198
  Deviation, 0.5                  (64.0%)   (64.5%)   (65.3%)   (60.9%)   (64.7%)               (63.6%)
  D‡                                                                                            

  Vector                          18/25     57/76     41/49     19/23     14/17     6/8 (75.0%) 155/198
  Deviation, 1.0                  (72.0%)   (75.0%)   (83.7%)   (82.6%)   (82.4%)               (78.3%)
  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                                                                    

  ‡               For eyes                                                                      
                  treated for                                                                   
                  astigmatic                                                                    
                  myopia.                                                                       
  --------------- --------------- --------- --------- --------- --------- --------- ----------- -----------

> When analyzed by treatment group, for the astigmatic myopia group (n=
> 224) in the 11.00 to 11.99 D stratum, 52.9% of eyes (versus
> recommended 60%) achieved MRSE within 1.00 D. For the spherical myopia
> group (n=80), there were only 3 eyes with MRSE 11.00 D, which was
> insufficient to support a determination of efficacy.
>
> One investigational site evidenced generally lower success rates than
> for the other investigational sites in the study. These decreased
> outcomes may be related to the use of smaller corneal flap diameters
> and larger treatment zone sizes chosen by the investigator at this
> site compared to those used at the other sites.

i.  Correction of Cylindrical Component

> The sponsor utilized the Sanders and Annello method for calculating
> vector change. This method was described in the PMA Supplement.
>
> Table 7 presents stratification by diopter of preoperative cylinder
> percent reduction of absolute cylinder and achieved vs. intended
> vector magnitude ratio (SIRC/IRC). The Intended Refractive Correction
> ("IRC") had a mean of 1.16 with a median of 1.00 (range 0.00 to 3.50).
> The Surgically Induced Refractive Correction ("SIRC") had a mean of
> 1.39 with a median of 1.23 (range 0.00 to 7.75). The vector magnitude
> ratio (SIRC/IRC) was 1.28 at 6 months.

**Table 7: Cylinder Correction Effectiveness Stratified By Preoperative
Cylinder - Astigmatic Myopia Eyes**

**With Complete Preoperative and Postoperative Refraction**

+---+--------+-----+--------+--------------+-----+--------+--------------+
| * |        | **P |        |              | *   |        |              |
| * |        | erc |        |              | *Ac |        |              |
| P |        | ent |        |              | hie |        |              |
| r |        | Red |        |              | ved |        |              |
| e |        | uct |        |              | vs  |        |              |
| o |        | ion |        |              | In  |        |              |
| p |        | of  |        |              | ten |        |              |
| e |        | Ab  |        |              | ded |        |              |
| r |        | sol |        |              | Vec |        |              |
| a |        | ute |        |              | tor |        |              |
| t |        | Cy  |        |              | Mag |        |              |
| i |        | lin |        |              | nit |        |              |
| v |        | der |        |              | ude |        |              |
| e |        | (   |        |              | Ra  |        |              |
| * |        | Not |        |              | tio |        |              |
| * |        | Ve  |        |              | (   |        |              |
|   |        | cto |        |              | SIR |        |              |
|   |        | r)\ |        |              | C/I |        |              |
|   |        | *** |        |              | RC) |        |              |
|   |        |     |        |              | †** |        |              |
+---+--------+-----+--------+--------------+-----+--------+--------------+
| * |        | **  | **Mean | **Median     | **  | **Mean | **Median     |
| * |        | N** | (SD)** | (Range)**    | N** | (SD)** | (Range)**    |
| C |        |     |        |              |     |        |              |
| y |        |     |        |              |     |        |              |
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| r |        |     |        |              |     |        |              |
| * |        |     |        |              |     |        |              |
| * |        |     |        |              |     |        |              |
+---+--------+-----+--------+--------------+-----+--------+--------------+
| * |        |     |        |              |     |        |              |
| * |        |     |        |              |     |        |              |
| 1 |        |     |        |              |     |        |              |
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| * |        |     |        |              |     |        |              |
+---+--------+-----+--------+--------------+-----+--------+--------------+
| \ |        | 87  | 56.51  | 100.00       | 90  | 1.21   | 1.00 (0.00   |
| < |        |     | (      | (-150.0 to   |     | (0.70) | to 4.36)     |
| 1 |        |     | 64.42) | 100.00)      |     |        |              |
| . |        |     |        |              |     |        |              |
| 0 |        |     |        |              |     |        |              |
| 0 |        |     |        |              |     |        |              |
| D |        |     |        |              |     |        |              |
+---+--------+-----+--------+--------------+-----+--------+--------------+
| 1 |        | 88  | 60.13  | 80.00        | 88  | 1.18   | 1.00 (0.28   |
| . |        |     | (      | (-725.0 to   |     | (0.78) | to 7.59)     |
| 0 |        |     | 92.14) | 100.00)      |     |        |              |
| 0 |        |     |        |              |     |        |              |
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| 9 |        |     |        |              |     |        |              |
| 9 |        |     |        |              |     |        |              |
| D |        |     |        |              |     |        |              |
+---+--------+-----+--------+--------------+-----+--------+--------------+
| 2 |        | 33  | 79.65  | 77.78 (37.50 | 33  | 1.13   | 1.00 (0.77   |
| . |        |     | (      | to 100.00)   |     | (0.19) | to 1.57)     |
| 0 |        |     | 20.27) |              |     |        |              |
| 0 |        |     |        |              |     |        |              |
| t |        |     |        |              |     |        |              |
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| 2 |        |     |        |              |     |        |              |
| . |        |     |        |              |     |        |              |
| 9 |        |     |        |              |     |        |              |
| 9 |        |     |        |              |     |        |              |
| D |        |     |        |              |     |        |              |
+---+--------+-----+--------+--------------+-----+--------+--------------+
| 3 |        | 7   | 95.92  | 100.00       | 7   | 1.00   | 1.00 (0.80   |
| . |        |     | (      | (71.43 to    |     | (0.10) | to 1.09)     |
| 0 |        |     | 10.80) | 100.00)      |     |        |              |
| 0 |        |     |        |              |     |        |              |
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| 9 |        |     |        |              |     |        |              |
| 9 |        |     |        |              |     |        |              |
| D |        |     |        |              |     |        |              |
+---+--------+-----+--------+--------------+-----+--------+--------------+
| T |        | 215 | 62.83  | 83.33        | 218 | 1.18   | 1.00 (0.00   |
| o |        |     | (      | (-725.0 to   |     | (0.67) | to 7.59)     |
| t |        |     | 72.68) | 100.00)      |     |        |              |
| a |        |     |        |              |     |        |              |
| l |        |     |        |              |     |        |              |
+---+--------+-----+--------+--------------+-----+--------+--------------+
| * |        |     |        |              |     |        |              |
| * |        |     |        |              |     |        |              |
| 3 |        |     |        |              |     |        |              |
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| l |        |     |        |              |     |        |              |
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| n |        |     |        |              |     |        |              |
| d |        |     |        |              |     |        |              |
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| * |        |     |        |              |     |        |              |
| * |        |     |        |              |     |        |              |
+---+--------+-----+--------+--------------+-----+--------+--------------+
| \ |        | 89  | 43.26  | 100.00       | 92  | 1.29   | 1.00 (0.00   |
| < |        |     | (      | (-166.7 to   |     | (0.83) | to 4.96)     |
| 1 |        |     | 71.89) | 100.00)      |     |        |              |
| . |        |     |        |              |     |        |              |
| 0 |        |     |        |              |     |        |              |
| 0 |        |     |        |              |     |        |              |
| D |        |     |        |              |     |        |              |
+---+--------+-----+--------+--------------+-----+--------+--------------+
| 1 |        | 87  | 56.50  | 71.43        | 87  | 1.23   | 1.00 (0.51   |
| . |        |     | (      | (-500.0 to   |     | (0.74) | to 6.88)     |
| 0 |        |     | 73.89) | 100.00)      |     |        |              |
| 0 |        |     |        |              |     |        |              |
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| 9 |        |     |        |              |     |        |              |
| 9 |        |     |        |              |     |        |              |
| D |        |     |        |              |     |        |              |
+---+--------+-----+--------+--------------+-----+--------+--------------+
| 2 |        | 33  | 76.97  | 75.00 (25.00 | 33  | 1.14   | 1.13 (0.72   |
| . |        |     | (      | to 100.00)   |     | (0.19) | to 1.74)     |
| 0 |        |     | 18.26) |              |     |        |              |
| 0 |        |     |        |              |     |        |              |
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| 9 |        |     |        |              |     |        |              |
| 9 |        |     |        |              |     |        |              |
| D |        |     |        |              |     |        |              |
+---+--------+-----+--------+--------------+-----+--------+--------------+
| 3 |        | 6   | 80.95  | 82.14 (50.00 | 6   | 1.13   | 1.10 (0.85   |
| . |        |     | (      | to 100.00)   |     | (0.24) | to 1.56)     |
| 0 |        |     | 18.99) |              |     |        |              |
| 0 |        |     |        |              |     |        |              |
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| 9 |        |     |        |              |     |        |              |
| 9 |        |     |        |              |     |        |              |
| D |        |     |        |              |     |        |              |
+---+--------+-----+--------+--------------+-----+--------+--------------+
| T |        | 215 | 54.84  | 75.00        | 218 | 1.24   | 1.00 (0.00   |
| o |        |     | (      | (-500.0 to   |     | (0.72) | to 6.88)     |
| t |        |     | 67.30) | 100.00)      |     |        |              |
| a |        |     |        |              |     |        |              |
| l |        |     |        |              |     |        |              |
+---+--------+-----+--------+--------------+-----+--------+--------------+
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+---+--------+-----+--------+--------------+-----+--------+--------------+
| \ |        | 80  | 29.37  | 33.33        | 81  | 1.39   | 1.00 (0.00   |
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| 1 |        | 83  | 57.55  | 66.67        | 83  | 1.23   | 1.00 (0.52   |
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+---+--------+-----+--------+--------------+-----+--------+--------------+

d.  **Safety Outcomes**

> The key safety variables for all treated eyes at 3 and 6 months are
> presented in Tables 8 and 9, with all the adverse events reported in
> table 10.

**Table 8: Key Safety Variables at 3 And 6 Months**

**All Treated Eyes**

+----------------------------------------+--------------+-------------+---+
| **Key Safety Events**                  | **All Eyes** |             |   |
+----------------------------------------+--------------+-------------+---+
|                                        | **n/N (%)**  |             |   |
+----------------------------------------+--------------+-------------+---+
|                                        | **3 Months** | **6         |   |
|                                        |              | Months**    |   |
+----------------------------------------+--------------+-------------+---+
| Loss of 2 lines BSCVA                  | 9/292 (3.1%) | 4/263       |   |
|                                        |              | (1.5%)      |   |
+----------------------------------------+--------------+-------------+---+
| Loss of \> 2 lines BSCVA               | 1/292 (0.3%) | 0/263       |   |
|                                        |              | (0.0%)      |   |
+----------------------------------------+--------------+-------------+---+
| BSCVA worse than 20/40                 | 1/292 (0.3%) | 1/263       |   |
|                                        |              | (0.4%)      |   |
+----------------------------------------+--------------+-------------+---+
| BSCVA worse than 20/25 if 20/20 or     | 7/272 (2.6%) | 2/240       |   |
| better preoperatively                  |              | (0.8%)      |   |
+----------------------------------------+--------------+-------------+---+
| Haze trace with loss of BSCVA \> 2     | 0/292 (0.0%) | 0/262       |   |
| lines                                  |              | (0.0%)      |   |
+----------------------------------------+--------------+-------------+---+
| Increased manifest refractive          | 0/73 (0.0%)  | 0/65 (0.0%) |   |
| astigmatism \> 2.0 D\*                 |              |             |   |
+----------------------------------------+--------------+-------------+---+
| N = Number of CRFs received with       |              |             |   |
| non-missing values at each visit.      |              |             |   |
|                                        |              |             |   |
| For eyes treated with spherical myopia |              |             |   |
| only.                                  |              |             |   |
+----------------------------------------+--------------+-------------+---+

**Table 9**

**Key Safety Variables at 6 Months Stratified by Preoperative MRSE**

**All Treated Eyes**

  ---------------- --------------- -------- -------- -------- --------- --------- -----------
  **Key Safety                     **7.00   **8.00   **9.00   **10.00   **11.00   
  Variables**                      to**     to**     to**     to**      to**      

                                   **7.99   **8.99   **9.99   **10.99   **11.99   **12.00**
                                   D**      D**      D**      D**       D**       

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

  Loss of 2 lines                  1/44     0/94     2/68     1/29      0/18      0/10 (0.0%)
  BSCVA                            (2.3%)   (0.0%)   (2.9%)   (3.4%)    (0.0%)    

  Loss of \> 2                     0/44     0/94     0/68     0/29      0/18      0/10 (0.0%)
  lines BSCVA                      (0.0%)   (0.0%)   (0.0%)   (0.0%)    (0.0%)    

  BSCVA worse than                 0/44     0/94     0/68     0/29      1/18      0/10 (0.0%)
  20/40                            (0.0%)   (0.0%)   (0.0%)   (0.0%)    (5.6%)    

  BSCVA worse than                 0/43     0/87     1/64     1/23      0/16      0/7 (0.0%)
  20/25 if 20/20                   (0.0%)   (0.0%)   (1.6%)   (4.3%)    (0.0%)    
  or better                                                                       
  preoperatively                                                                  

  Haze trace with                  0/43     0/94     0/68     0/29      0/18      0/10 (0.0%)
  loss of BSCVA \>                 (0.0%)   (0.0%)   (0.0%)   (0.0%)    (0.0%)    
  2 lines                                                                         

  Increased                        0/19     0/18     0/19     0/6       0/1       0/2 (0.0%)
  manifest                         (0.0%)   (0.0%)   (0.0%)   (0.0%)    (0.0%)    
  refractive                                                                      
  astigmatism \>                                                                  
  2.0 D\*                                                                         

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

  \*               For eyes                                                       
                   treated for                                                    
                   spherical                                                      
                   myopia only.                                                   
  ---------------- --------------- -------- -------- -------- --------- --------- -----------

> Table 10 provides a listing of all adverse events reported during the
> study at each visit period along with the overall cumulative adverse
> event rate. The cumulative adverse event rate for all reported events
> was quite low, with only one category (lamellar keratitis) exceeding
> 1.0% on a cumulative basis.

**Table 10: Adverse Events Summary - All Treated Eyes**

+---+--------------+--------+--------+--------+--------+--------+--------+
| > |              | **1    | **7    | **1    | **3    | **6    | **     |
|   |              | Day**  | Day**  | M      | Mo     | Mo     | Cumula |
| * |              |        |        | onth** | nths** | nths** | tive** |
| * |              |        |        |        |        |        |        |
| A |              |        |        |        |        |        |        |
| l |              |        |        |        |        |        |        |
| l |              |        |        |        |        |        |        |
| > |              |        |        |        |        |        |        |
|   |              |        |        |        |        |        |        |
| R |              |        |        |        |        |        |        |
| e |              |        |        |        |        |        |        |
| p |              |        |        |        |        |        |        |
| o |              |        |        |        |        |        |        |
| r |              |        |        |        |        |        |        |
| t |              |        |        |        |        |        |        |
| e |              |        |        |        |        |        |        |
| d |              |        |        |        |        |        |        |
| * |              |        |        |        |        |        |        |
| * |              |        |        |        |        |        |        |
+---+--------------+--------+--------+--------+--------+--------+--------+
| * |              | **n/N  | **n/N  | **n/N  | **n/N  | **n/N  | **n/N  |
| * |              | (%)**  | (%)**  | (%)**  | (%)**  | (%)**  | (%)**  |
| A |              |        |        |        |        |        |        |
| d |              |        |        |        |        |        |        |
| v |              |        |        |        |        |        |        |
| e |              |        |        |        |        |        |        |
| r |              |        |        |        |        |        |        |
| s |              |        |        |        |        |        |        |
| e |              |        |        |        |        |        |        |
| E |              |        |        |        |        |        |        |
| v |              |        |        |        |        |        |        |
| e |              |        |        |        |        |        |        |
| n |              |        |        |        |        |        |        |
| t |              |        |        |        |        |        |        |
| s |              |        |        |        |        |        |        |
| * |              |        |        |        |        |        |        |
| * |              |        |        |        |        |        |        |
+---+--------------+--------+--------+--------+--------+--------+--------+
| A |              | 0/304  | 0/282  | 0/294  | 0/292  | 0/263  | 1/308  |
| n |              | (0.0%) | (0.0%) | (0.0%) | (0.0%) | (0.0%) | (0.3%) |
| y |              |        |        |        |        |        |        |
| c |              |        |        |        |        |        |        |
| o |              |        |        |        |        |        |        |
| r |              |        |        |        |        |        |        |
| n |              |        |        |        |        |        |        |
| e |              |        |        |        |        |        |        |
| a |              |        |        |        |        |        |        |
| l |              |        |        |        |        |        |        |
| e |              |        |        |        |        |        |        |
| p |              |        |        |        |        |        |        |
| i |              |        |        |        |        |        |        |
| t |              |        |        |        |        |        |        |
| h |              |        |        |        |        |        |        |
| e |              |        |        |        |        |        |        |
| l |              |        |        |        |        |        |        |
| i |              |        |        |        |        |        |        |
| a |              |        |        |        |        |        |        |
| l |              |        |        |        |        |        |        |
| d |              |        |        |        |        |        |        |
| e |              |        |        |        |        |        |        |
| f |              |        |        |        |        |        |        |
| e |              |        |        |        |        |        |        |
| c |              |        |        |        |        |        |        |
| t |              |        |        |        |        |        |        |
| i |              |        |        |        |        |        |        |
| n |              |        |        |        |        |        |        |
| v |              |        |        |        |        |        |        |
| o |              |        |        |        |        |        |        |
| l |              |        |        |        |        |        |        |
| v |              |        |        |        |        |        |        |
| i |              |        |        |        |        |        |        |
| n |              |        |        |        |        |        |        |
| g |              |        |        |        |        |        |        |
| t |              |        |        |        |        |        |        |
| h |              |        |        |        |        |        |        |
| e |              |        |        |        |        |        |        |
| k |              |        |        |        |        |        |        |
| e |              |        |        |        |        |        |        |
| r |              |        |        |        |        |        |        |
| a |              |        |        |        |        |        |        |
| t |              |        |        |        |        |        |        |
| e |              |        |        |        |        |        |        |
| c |              |        |        |        |        |        |        |
| t |              |        |        |        |        |        |        |
| o |              |        |        |        |        |        |        |
| m |              |        |        |        |        |        |        |
| y |              |        |        |        |        |        |        |
+---+--------------+--------+--------+--------+--------+--------+--------+
| C |              | 0/304  | 0/282  | 1/294  | 0/292  | 0/263  | 1/308  |
| o |              | (0.0%) | (0.0%) | (0.3%) | (0.0%) | (0.0%) | (0.3%) |
| r |              |        |        |        |        |        |        |
| n |              |        |        |        |        |        |        |
| e |              |        |        |        |        |        |        |
| a |              |        |        |        |        |        |        |
| l |              |        |        |        |        |        |        |
| e |              |        |        |        |        |        |        |
| d |              |        |        |        |        |        |        |
| e |              |        |        |        |        |        |        |
| m |              |        |        |        |        |        |        |
| a |              |        |        |        |        |        |        |
| ( |              |        |        |        |        |        |        |
| f |              |        |        |        |        |        |        |
| l |              |        |        |        |        |        |        |
| a |              |        |        |        |        |        |        |
| p |              |        |        |        |        |        |        |
| ) |              |        |        |        |        |        |        |
| a |              |        |        |        |        |        |        |
| t |              |        |        |        |        |        |        |
| \ |              |        |        |        |        |        |        |
| > |              |        |        |        |        |        |        |
| 1 |              |        |        |        |        |        |        |
| m |              |        |        |        |        |        |        |
| o |              |        |        |        |        |        |        |
| n |              |        |        |        |        |        |        |
| t |              |        |        |        |        |        |        |
| h |              |        |        |        |        |        |        |
+---+--------------+--------+--------+--------+--------+--------+--------+
| F |              | 1/304  | 0/282  | 1/294  | 0/292  | 0/263  | 2/308  |
| o |              | (0.3%) | (0.0%) | (0.3%) | (0.0%) | (0.0%) | (0.6%) |
| l |              |        |        |        |        |        |        |
| d |              |        |        |        |        |        |        |
| s |              |        |        |        |        |        |        |
| i |              |        |        |        |        |        |        |
| n |              |        |        |        |        |        |        |
| f |              |        |        |        |        |        |        |
| l |              |        |        |        |        |        |        |
| a |              |        |        |        |        |        |        |
| p |              |        |        |        |        |        |        |
+---+--------------+--------+--------+--------+--------+--------+--------+
| L |              | 5/304  | 2/282  | 0/294  | 0/292  | 0/263  | 6/308  |
| a |              | (1.6%) | (0.7%) | (0.0%) | (0.0%) | (0.0%) | (1.9%) |
| m |              |        |        |        |        |        |        |
| e |              |        |        |        |        |        |        |
| l |              |        |        |        |        |        |        |
| l |              |        |        |        |        |        |        |
| a |              |        |        |        |        |        |        |
| r |              |        |        |        |        |        |        |
| k |              |        |        |        |        |        |        |
| e |              |        |        |        |        |        |        |
| r |              |        |        |        |        |        |        |
| a |              |        |        |        |        |        |        |
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| i |              |        |        |        |        |        |        |
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| s |              |        |        |        |        |        |        |
+---+--------------+--------+--------+--------+--------+--------+--------+
| L |              | 0/304  | 0/282  | 0/294  | 0/292  | 2/263  | 2/308  |
| a |              | (0.0%) | (0.0%) | (0.0%) | (0.0%) | (0.8%) | (0.6%) |
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+---+--------------+--------+--------+--------+--------+--------+--------+
| S |              | 1/304  | 1/282  | 1/294  | 0/292  | 0/263  | 3/308  |
| e |              | (0.3%) | (0.4%) | (0.3%) | (0.0%) | (0.0%) | (1.0%) |
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+---+--------------+--------+--------+--------+--------+--------+--------+
| S |              | 0/304  | 1/282  | 0/294  | 0/292  | 0/263  | 1/308  |
| t |              | (0.0%) | (0.4%) | (0.0%) | (0.0%) | (0.0%) | (0.3%) |
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+---+--------------+--------+--------+--------+--------+--------+--------+
| V |              | 0/304  | 0/282  | 1/294  | 0/292  | 0/263  | 1/308  |
| i |              | (0.0%) | (0.0%) | (0.3%) | (0.0%) | (0.0%) | (0.3%) |
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+---+--------------+--------+--------+--------+--------+--------+--------+
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+---+--------------+--------+--------+--------+--------+--------+--------+
| T |              | 304    | 282    | 294    | 292    | 263    | 308    |
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+---+--------------+--------+--------+--------+--------+--------+--------+
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+---+--------------+--------+--------+--------+--------+--------+--------+
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| . |              |        |        |        |        |        |        |
+---+--------------+--------+--------+--------+--------+--------+--------+
| T |              |        |        |        |        |        |        |
| h |              |        |        |        |        |        |        |
| e |              |        |        |        |        |        |        |
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| 1 |              |        |        |        |        |        |        |
| . |              |        |        |        |        |        |        |
| 9 |              |        |        |        |        |        |        |
| % |              |        |        |        |        |        |        |
| . |              |        |        |        |        |        |        |
+---+--------------+--------+--------+--------+--------+--------+--------+
| \ | Number of    |        |        |        |        |        |        |
| * | CRFs         |        |        |        |        |        |        |
|   | received     |        |        |        |        |        |        |
|   | with missing |        |        |        |        |        |        |
|   | values at    |        |        |        |        |        |        |
|   | each visit.  |        |        |        |        |        |        |
+---+--------------+--------+--------+--------+--------+--------+--------+
| † | Number of    |        |        |        |        |        |        |
|   | CRFs         |        |        |        |        |        |        |
|   | received at  |        |        |        |        |        |        |
|   | each visit.  |        |        |        |        |        |        |
+---+--------------+--------+--------+--------+--------+--------+--------+

> Table 11 presents a summary of all complications reported for all
> treated eyes during the course of the study.

**Table 11: Complications Summary - All Treated Eyes**

  ----------------- ------------------ ---------- ---------- ---------- ---------- ----------
  **All Reported                       **1 Day**  **7 Days** **1        **3        **6
  Complications**                                            Month**    Months**   Months**

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

  Abrasion                             2/303      0/282      0/294      0/292      0/263
                                       (0.7%)     (0.0%)     (0.0%)     (0.0%)     (0.0%)

  Anterior basement                    0/303      0/282      0/294      0/292      2/263
  membrane change                      (0.0%)     (0.0%)     (0.0%)     (0.0%)     (0.8%)

  Conjunctivitis                       0/303      0/282      1/294      3/292      1/263
                                       (0.0%)     (0.0%)     (0.3%)     (1.0%)     (0.4%)

  Corneal abrasion                     3/303      0/282      0/294      0/292      0/263
                                       (1.0%)     (0.0%)     (0.0%)     (0.0%)     (0.0%)

  Corneal edema at                     0/303      10/282     6/294      0/292      0/263
  1 month                              (0.0%)     (3.5%)     (2.0%)     (0.0%)     (0.0%)

  Debris in                            35/303     24/282     18/294     11/292     8/263
  interface                            (11.6%)    (8.5%)     (6.1%)     (3.8%)     (3.0%)

  Epithelial defect                    1/303      0/282      0/294      0/292      0/263
                                       (0.3%)     (0.0%)     (0.0%)     (0.0%)     (0.0%)

  Epithelial                           0/303      0/282      1/294      0/292      0/263
  irregularity                         (0.0%)     (0.0%)     (0.3%)     (0.0%)     (0.0%)

  Epithelial                           1/303      0/282      0/294      0/292      0/263
  vacuoles                             (0.3%)     (0.0%)     (0.0%)     (0.0%)     (0.0%)

  Epithelium in the                    0/303      0/282      1/294      2/292      1/263
  interface with                       (0.0%)     (0.0%)     (0.3%)     (0.7%)     (0.4%)
  loss 2 lines of                                                                  
  BSCVA                                                                            

  Folds in flap                        1/303      0/282      14/294     14/292     11/263
                                       (0.3%)     (0.0%)     (4.8%)     (4.8%)     (4.2%)

  Lamellar                             0/303      0/282      0/294      1/292      0/263
  keratitis                            (0.0%)     (0.0%)     (0.0%)     (0.3%)     (0.0%)

  Peripheral                           1/303      0/282      0/294      0/292      0/263
  corneal                              (0.3%)     (0.0%)     (0.0%)     (0.0%)     (0.0%)
  epithelial defect                                                                
  (across the flap                                                                 
  junction)                                                                        

  Peripheral                           2/303      0/282      0/294      0/292      0/263
  corneal                              (0.7%)     (0.0%)     (0.0%)     (0.0%)     (0.0%)
  epithelial defect                                                                
  (on the flap)                                                                    

  Striae in flap                       0/303      0/282      1/294      4/292      1/263
                                       (0.0%)     (0.0%)     (0.3%)     (1.4%)     (0.4%)

  Subconjunctival                      4/303      6/282      0/294      0/292      0/263
  hemorrhage                           (1.3%)     (2.1%)     (0.0%)     (0.0%)     (0.0%)

  Vitreous                             0/303      0/282      0/294      0/292      2/263
  detachment                           (0.0%)     (0.0%)     (0.0%)     (0.0%)     (0.8%)

  Not reported\*                       1          0          0          0          0

  Total†                               304        282        294        292        263

  2 DEBRIS IN                                                                      
  INTERFACE, & 1                                                                   
  FOLDS IN FLAP                                                                    
  were reported at                                                                 
  an interim visit                                                                 
  between 1 day to                                                                 
  7 days postop. 1                                                                 
  DEBRIS IN                                                                        
  INTERFACE was                                                                    
  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 12 presents the changes in patient symptoms from baseline for
> all treated eyes at 3 and 6 months postoperative. Those categories in
> which there was a clinically significant greater percentage ( 5%
> difference) of eyes reporting that symptoms were worse rather than
> better at 6 months include glare, halos, blurred vision, double
> vision, ghost images, fluctuation of vision, variation of vision in
> normal light, variation of vision in dim light, and night driving
> vision.

**Table 12: Patient Symptoms Change from Baseline - All Treated Eyes**

  ----------------- ------------ ---------- ----------- ------------ ---------- -----------
  **Patient         **3 Months**                        **6 Months**            
  Symptoms**                                                                    

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

                    **Better**   **No       **Worse**   **Better**   **No       **Worse**
                                 Change**                            Change**   

  Light sensitivity 111/267      110/267    46/267      95/224       105/224    24/224
                    (41.6)       (41.2)     (17.2)      (42.4)       (46.9)     (10.7)

  Headaches         79/267       167/267    21/267      63/224       145/224    16/224
                    (29.6)       (62.5)     (7.9)       (28.1)       (64.7)     (7.1)

  Pain              14/267 (5.2) 236/267    17/267      14/224 (6.3) 198/224    12/224
                                 (88.4)     (6.4)                    (88.4)     (5.4)

  Redness           54/267       190/267    23/267      48/224       164/224    12/224
                    (20.2)       (71.2)     (8.6)       (21.4)       (73.2)     (5.4)

  Dryness           48/267       135/267    84/267      64/224       112/224    48/224
                    (18.0)       (50.6)     (31.5)      (28.6)       (50.0)     (21.4)

  Tearing           22/267 (8.2) 232/267    13/267      18/224 (8.0) 191/224    15/224
                                 (86.9)     (4.9)                    (85.3)     (6.7)

  Burning           35/267       194/267    38/267      37/224       165/224    22/224
                    (13.1)       (72.7)     (14.2)      (16.5)       (73.7)     (9.8)

  Gritty feeling    24/267 (9.0) 210/267    33/267      20/224 (8.9) 177/224    27/224
                                 (78.7)     (12.4)                   (79.0)     (12.1)

  Glare             48/267       119/267    100/267     55/224       102/224    67/224
                    (18.0)       (44.6)     (37.5)      (24.6)       (45.5)     (29.9)

  Halos             35/267       112/267    120/267     35/224       93/224     96/224
                    (13.1)       (41.9)     (44.9)      (15.6)       (41.5)     (42.9)

  Blurred vision    58/267       99/267     110/267     51/224       88/224     85/224
                    (21.7)       (37.1)     (41.2)      (22.8)       (39.3)     (37.9)

  Double vision     2/267 (0.7)  243/267    22/267      3/224 (1.3)  202/224    19/224
                                 (91.0)     (8.2)                    (90.2)     (8.5)

  Ghost images      15/267 (5.6) 196/267    56/267      16/224 (7.1) 166/224    42/224
                                 (73.4)     (21.0)                   (74.1)     (18.8)

  Fluctuations of   33/267       110/267    124/267     27/224       115/224    82/224
  vision            (12.4)       (41.2)     (46.4)      (12.1)       (51.3)     (36.6)

  Variation of      60/267       157/267    50/267      46/224       142/224    36/224
  vision in bright  (22.5)       (58.8)     (18.7)      (20.5)       (63.4)     (16.1)
  light                                                                         

  Variation of      22/267 (8.2) 173/267    72/267      21/224 (9.4) 141/224    62/224
  vision in normal               (64.8)     (27.0)                   (62.9)     (27.7)
  light                                                                         

  Variation of      34/267       126/267    107/267     31/224       110/224    83/224
  vision in dim     (12.7)       (47.2)     (40.1)      (13.8)       (49.1)     (37.1)
  light                                                                         

  Night driving     55/267       113/267    99/267      47/224       95/224     82/224
  vision            (20.6)       (42.3)     (37.1)      (21.0)       (42.4)     (36.6)

  Astigmatism       0/267 (0.0)  267/267    0/267 (0.0) 0/224 (0.0)  222/224    2/224 (0.9)
                                 (100.0)                             (99.1)     

  Discharge         1/267 (0.4)  266/267    0/267 (0.0) 1/224 (0.4)  223/224    0/224 (0.0)
                                 (99.6)                              (99.6)     

  Edema             0/267 (0.0)  265/267    2/267 (0.7) 0/224 (0.0)  224/224    0/224 (0.0)
                                 (99.3)                              (100.0)    

  Eye strain        0/267 (0.0)  266/267    1/267 (0.4) 0/224 (0.0)  223/224    1/224 (0.4)
                                 (99.6)                              (99.6)     

  Floaters          8/267 (3.0)  259/267    0/267 (0.0) 8/224 (3.6)  216/224    0/224 (0.0)
                                 (97.0)                              (96.4)     

  Haze              0/267 (0.0)  267/267    0/267 (0.0) 0/224 (0.0)  224/224    0/224 (0.0)
                                 (100.0)                             (100.0)    

  Infection         2/267 (0.7)  265/267    0/267 (0.0) 0/224 (0.0)  224/224    0/224 (0.0)
                                 (99.3)                              (100.0)    

  Itching           4/267 (1.5)  263/267    0/267 (0.0) 4/224 (1.8)  220/224    0/224 (0.0)
                                 (98.5)                              (98.2)     

  Light flash       0/267 (0.0)  266/267    1/267 (0.4) 0/224 (0.0)  224/224    0/224 (0.0)
                                 (99.6)                              (100.0)    

  Myopic regression 0/267 (0.0)  266/267    1/267 (0.4) 0/224 (0.0)  224/224    0/224 (0.0)
                                 (99.6)                              (100.0)    

  Starburst         1/267 (0.4)  264/267    2/267 (0.7) 0/224 (0.0)  224/224    0/224 (0.0)
                                 (98.9)                              (100.0)    

  Twitch            0/267 (0.0)  266/267    1/267 (0.4) 0/224 (0.0)  223/224    1/224 (0.4)
                                 (99.6)                              (99.6)     

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

  12 3-Month postop                                                             
  evaluation CRFs                                                               
  did not have the                                                              
  respective preop                                                              
  evaluation CRFs.                                                              

  10 6-Month postop                                                             
  evaluation CRFs                                                               
  did not have the                                                              
  respective preop                                                              
  evaluation CRFs.                                                              

  4 preop.                                                                      
  Evaluation CRFs                                                               
  did not have any                                                              
  postop evaluation                                                             
  CRFs.                                                                         
  ----------------- ------------ ---------- ----------- ------------ ---------- -----------

###  {#section-6 .unnumbered}

# Table 12.A presents all patient symptoms graded at 6 months as moderate or worse. It can be seen that those symptoms reported at 6 months postoperative fall predominantly into the mild category, which are not considered to be clinically significant. 

**Table 12.A**

**Patient Symptoms at Preop & 6 Months**

**All Treated Eyes**

  ----------------- ------------ ---------- ------------ ---------- -------------- ----------
  **Patient         **None**                **Mild**                **Moderate**   
  Symptoms**                                                                       

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

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

  Light sensitivity 99/293       116/234    106/293      99/234     88/293 (30.0%) 19/234
                    (33.8%)      (49.6%)    (36.2%)      (42.3%)                   (8.1%)

  Headaches         168/293      184/234    95/293       34/234     30/293 (10.2%) 16/234
                    (57.3%)      (78.6%)    (32.4%)      (14.5%)                   (6.8%)

  Pain              271/293      216/234    20/293       15/234     2/293 (0.7%)   3/234
                    (92.5%)      (92.3%)    (6.8%)       (6.4%)                    (1.3%)

  Redness           174/293      176/234    100/293      52/234     19/293 (6.5%)  6/234
                    (59.4%)      (75.2%)    (34.1%)      (22.2%)                   (2.6%)

  Dryness           125/293      101/234    120/293      105/234    48/293 (16.4%) 28/234
                    (42.7%)      (43.2%)    (41.0%)      (44.9%)                   (12.0%)

  Tearing           264/293      217/234    27/293       15/234     2/293 (0.7%)   2/234
                    (90.1%)      (92.7%)    (9.2%)       (6.4%)                    (0.9%)

  Burning           233/293      192/234    48/293       41/234     12/293 (4.1%)  1/234
                    (79.5%)      (82.1%)    (16.4%)      (17.5%)                   (0.4%)

  Gritty feeling    250/293      196/234    33/293       33/234     10/293 (3.4%)  5/234
                    (85.3%)      (83.8%)    (11.3%)      (14.1%)                   (2.1%)

  Glare             166/293      118/234    81/293       90/234     46/293 (15.7%) 26/234
                    (56.7%)      (50.4%)    (27.6%)      (38.5%)                   (11.1%)

  Halos             175/293      86/234     82/293       106/234    36/293 (12.3%) 42/234
                    (59.7%)      (36.8%)    (28.0%)      (45.3%)                   (17.9%)

  Blurred vision    175/293      105/234    63/293       85/234     55/293 (18.8%) 44/234
                    (59.7%)      (44.9%)    (21.5%)      (36.3%)                   (18.8%)

  Double vision     281/293      211/234    6/293 (2.0%) 12/234     6/293 (2.0%)   11/234
                    (95.9%)      (90.2%)                 (5.1%)                    (4.7%)

  Ghost images      256/293      183/234    31/293       38/234     6/293 (2.0%)   13/234
                    (87.4%)      (78.2%)    (10.6%)      (16.2%)                   (5.6%)

  Fluctuations of   212/293      115/234    61/293       95/234     20/293 (6.8%)  24/234
  vision            (72.4%)      (49.1%)    (20.8%)      (40.6%)                   (10.3%)

  Variation of      196/293      169/234    68/293       52/234     29/293 (9.9%)  13/234
  vision in bright  (66.9%)      (72.2%)    (23.2%)      (22.2%)                   (5.6%)
  light                                                                            

  Variation of      247/293      159/234    38/293       65/234     8/293 (2.7%)   10/234
  vision in normal  (84.3%)      (67.9%)    (13.0%)      (27.8%)                   (4.3%)
  light                                                                            

  Variation of      148/293      86/234     101/293      89/234     44/293 (15.0%) 59/234
  vision in dim     (50.5%)      (36.8%)    (34.5%)      (38.0%)                   (25.2%)
  light                                                                            

  Night driving     107/293      62/234     111/293      105/234    75/293 (25.6%) 67/234
  vision            (36.5%)      (26.5%)    (37.9%)      (44.9%)                   (28.6%)

  Astigmatism       293/293      232/234    0/293 (0.0%) 2/234      0/293 (0.0%)   0/234
                    (100.0%)     (99.1%)                 (0.9%)                    (0.0%)

  Discharge         292/293      234/234    0/293 (0.0%) 0/234      1/293 (0.3%)   0/234
                    (99.7%)      (100.0%)                (0.0%)                    (0.0%)

  Edema             293/293      234/234    0/293 (0.0%) 0/234      0/293 (0.0%)   0/234
                    (100.0%)     (100.0%)                (0.0%)                    (0.0%)

  Eye strain        293/293      233/234    0/293 (0.0%) 1/234      0/293 (0.0%)   0/234
                    (100.0%)     (99.6%)                 (0.4%)                    (0.0%)

  Floaters          285/293      234/234    6/293 (2.0%) 0/234      2/293 (0.7%)   0/234
                    (97.3%)      (100.0%)                (0.0%)                    (0.0%)

  Haze              293/293      234/234    0/293 (0.0%) 0/234      0/293 (0.0%)   0/234
                    (100.0%)     (100.0%)                (0.0%)                    (0.0%)

  Infection         291/293      234/234    2/293 (0.7%) 0/234      0/293 (0.0%)   0/234
                    (99.3%)      (100.0%)                (0.0%)                    (0.0%)

  Itching           289/293      234/234    4/293 (1.4%) 0/234      0/293 (0.0%)   0/234
                    (98.6%)      (100.0%)                (0.0%)                    (0.0%)

  Light flash       293/293      234/234    0/293 (0.0%) 0/234      0/293 (0.0%)   0/234
                    (100.0%)     (100.0%)                (0.0%)                    (0.0%)

  Myopic regression 293/293      234/234    0/293 (0.0%) 0/234      0/293 (0.0%)   0/234
                    (100.0%)     (100.0%)                (0.0%)                    (0.0%)

  Starburst         292/293      234/234    1/293 (0.3%) 0/234      0/293 (0.0%)   0/234
                    (99.7%)      (100.0%)                (0.0%)                    (0.0%)

  Twitch            293/293      233/234    0/293 (0.0%) 1/234      0/293 (0.0%)   0/234
                    (100.0%)     (99.6%)                 (0.4%)                    (0.0%)

  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 halos,                                                                      
  double vision,                                                                   
  ghost images,                                                                    
  fluctuations of                                                                  
  vision, variation                                                                
  of vision in                                                                     
  normal light,                                                                    
  variation of                                                                     
  vision in dim                                                                    
  light, and night                                                                 
  driving vision.                                                                  
  ----------------- ------------ ---------- ------------ ---------- -------------- ----------

> **e. Retreatment**
>
> Eight (8) eyes underwent LASIK retreatment during the study. (Seven of
> these eyes were discontinued prior to their 6-month visit and 1 eye
> after the 6-month visit due to low myopia LASIK retreatment with the
> Technolas laser.) The small number of retreatments is insufficient to
> yield clinically useful information
>
> **f. Factors Associated with Outcomes**
>
> Gender, preoperative refraction, age, primary vs. fellow eye, and
> study site were evaluated as statistically significant predictors of
> the UCVA and refractive outcome for the LASIK procedure. These
> analyses show the following:
>
> 1\) For UCVA of 20/40 or better at 3 and 6 months postoperative, the
> primary (first) eye treated for any patient is associated with a lower
> success rate.
>
> 2\) There are no statistically significant predictors for deviation
> from attempted spherical correction within 1.00 D at 3 and 6 months.
> However, for deviation within 0.50 D of attempted correction at 3 and
> 6 months, age, study site and preoperative sphere are predictors. An
> older subject is associated with a lower success rate. Also, a larger
> preoperative sphere is associated with a lower success rate. Lastly,
> one particular investigational site had a relatively lower success
> rate than the other investigational sites for this parameter.

3)  For manifest cylinder vector deviation 1.00 D at 3 and 6 months
    postoperative, preoperative cylinder amount and gender were
    significant predictors. A higher preoperative cylinder is associated
    with a higher success rate, and male gender is also associated with
    a higher success rate. For manifest vector deviation 0.50 D at 3 and
    6 months, one particular study site (the same one as in item 2)
    above) was associated with a relatively lower success rate for this
    parameter.

> **g. Patient Satisfaction**
>
> Responses provided by the study subjects at 6 months to three
> questions regarding their experiences with the laser surgery are
> provided in Table 13. 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.
>
> The overall quality of vision was rated highly, with 95.2% of patients
> (by eye) indicating that there was an extreme or marked improvement,
> while only 1.3% indicated that there was only slight or no
> improvement; 92.1% would elect to have the surgery again; 74.8%
> reported being very satisfied, and 19.6% were moderately satisfied,
> while 1.7% were dissatisfied and 0.9% were very dissatisfied.

**Table 13: Self-Evaluation at 6 Months**

**Overall Quality of Vision, Choose Again, & Satisfaction - All Treated
Eyes**

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

                                      **[n/N               **[n/N               **[n/N
                                      (%)]{.underline}**   (%)]{.underline}**   (%)]{.underline}**

  Overall Quality of  No Improvement  0/232 (0.0%)         0/56 (0.0%)          0/176 (0.0%)
  Vision                                                                        

  After Excimer Laser Slight          3/232 (1.3%)         1/56 (1.8%)          2/176 (1.1%)
                      Improvement                                               

                      Moderate        8/232 (3.4%)         0/56 (0.0%)          8/176 (4.5%)
                      Improvement                                               

                      Marked          46/232 (19.8%)       13/56 (23.2%)        33/176 (18.8%)
                      Improvement                                               

                      Extreme         175/232 (75.4%)      42/56 (75.0%)        133/176 (75.6%)
                      Improvement                                               

                      Not reported\*  2                    0                    2

                      Total†          234                  56                   178

  Choose Excimer      No              9/228 (3.9%)         5/56 (8.9%)          4/172 (2.3%)
  Again?                                                                        

                      Unsure          9/228 (3.9%)         1/56 (1.8%)          8/172 (4.7%)

                      Yes             210/228 (92.1%)      50/56 (89.3%)        160/172 (93.0%)

                      Not reported\*  6                    0                    6

                      Total†          234                  56                   178

  How Satisfied with  Very Satisfied  172/230 (74.8%)      40/56 (71.4%)        132/174 (75.9%)
  the                                                                           

  Excimer Laser       Moderately      45/230 (19.6%)       13/56 (23.2%)        32/174 (18.4%)
  Results?            Satisfied                                                 

                      Neutral         7/230 (3.0%)         1/56 (1.8%)          6/174 (3.4%)

                      Dissatisfied    4/230 (1.7%)         2/56 (3.6%)          2/174 (1.1%)

                      Very            2/230 (0.9%)         0/56 (0.0%)          2/174 (1.1%)
                      Dissatisfied                                              

                      Not reported\*  4                    0                    4

                      Total†          234                  56                   178
  ------------------- --------------- -------------------- -------------------- --------------------

> **h. Device Failures and Replacements**
>
> There were three device failures/malfunctions and there were no device
> replacements during the course of the study. The three failures were
> related to poor corneal flap creation with the microkeratome. One
> LASIK procedure was aborted (no excimer laser treatment), and the
> other two LASIK procedures were completed as planned.

IX. **CONCLUSIONS DRAWN FROM THE STUDIES**

> The preclinical studies completed for this device did not raise any
> new safety or effectiveness concerns. Clinical studies demonstrated
> that safety and effectiveness parameters fell within acceptable FDA
> criteria providing reasonable assurance that the device is safe and
> effective when used in accordance with the directions for use.

### PANEL RECOMMENDATION

> 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

> CDRH issued an approval order on May 17, 2002. 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

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