**SUMMARY OF SAFETY AND EFFECTIVENESS**

**FOR A SUPPLEMENTAL PREMARKET APPLICATION**

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

Device Generic Name: Ophthalmic Medical Laser System

> (193 nanometer wavelength)

Device Trade Name: LaserSight LaserScan LSX Excimer Laser System

Applicant\'s Name and Address: LaserSight Technologies, Inc.

3300 University Blvd., Suite 140

> Winter Park, Florida 32792
>
> \(407\) 678-9900

Premarket Approval (PMA) Application Number: P980008/S5

Date of Panel Recommendation: None

Date of Notice of Approval to Applicant: September 28, 2001

> The LaserScan LSX Excimer Laser was approved on November 12, 1999
> under P980008 for the indication of photorefractive keratectomy for
> the reduction or elimination of myopia ranging from --1.0 to less than
> --6.0 diopters (D) with less than or equal to 1.0 D of 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 P980008 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, rm. 1061, Rockville, MD 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 LaserScan LSX Excimer Laser is intended for laser-assisted in situ
> keratomileusis (LASIK):

-   for the reduction or elimination of myopia ranging from --0.5 to
    less than --6.0 diopters (D) spherical equivalent, with astigmatism
    less than or equal to 4.5 D, as measured at the spectacle plane;

```{=html}
<!-- -->
```
-   

```{=html}
<!-- -->
```
-   in patients with documentation of a stable manifest refraction
    defined as [\<]{.underline} 0.50 D, or [\<]{.underline} 10% of
    preoperative spherical equivalent refraction (SER) shift over one
    year prior to surgery; and,

-   in patients who are 18 years of age or older.

**III.** **[CONTRAINDICATIONS]{.underline}**

> Patients with the following conditions should not be considered for
> LASIK surgery:

-   Active ocular / systemic infection in operative eye;

-   Fuch's corneal dystrophy in either eye;

-   Keratoconous in either eye;

-   Central corneal scars affecting visual acuity;

-   Autoimmune or immunodeficiency diseases;

```{=html}
<!-- -->
```
-   Pregnant or nursing women; or,

-   Taking one or both of the following medications: isotretinoin
    (Acutane) and amiodarone hydrochloride (Cordarone)

```{=html}
<!-- -->
```
-   

## IV. [WARNINGS AND PRECAUTIONS]{.underline}

## 

-   
-   
-   

2.  

## The warnings and precautions can be found in the labeling.

V.  

### 

### 

-   
-   
-   

```{=html}
<!-- -->
```
-   
-   
-   
-   
-   
-   
-   
-   
-   

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

> The LaserSight LaserScan LSX Excimer Laser System (henceforth, to be
> called the LSX) that is the subject of this supplement differs from
> the unit previously approved for PRK in the amount of correction to be
> provided for a given refractive error (i.e., different treatment
> nomograms for LASIK and PRK). Except for that one nomogram difference,
> the other ablation characteristics (e.g., fluence, repetition rate,
> and shot placement) remain the same.
>
> The operative laser parameters are summarized as follows.

[]{.mark}

+----------------+-------------------+---------------------------------+
| LaserScan LSX  |                   |                                 |
| Excimer Laser  |                   |                                 |
| Parameters     |                   |                                 |
+----------------+-------------------+---------------------------------+
| Pulse Rate:    |                   |                                 |
| 100 Hz         |                   |                                 |
|                |                   |                                 |
| Fluence: 80 -  |                   |                                 |
| 100 mJ/cm      |                   |                                 |
+----------------+-------------------+---------------------------------+
| Ablation Zone  |                   |                                 |
| Size           |                   |                                 |
+----------------+-------------------+---------------------------------+
| SER            | Maximum Ablation  | Maximum                         |
|                | Zone              |                                 |
|                |                   | Transition Zone (mm)            |
|                | \(mm\)            |                                 |
+----------------+-------------------+---------------------------------+
| \< 6.0 D       | 6.0               | 7.0                             |
+----------------+-------------------+---------------------------------+

> The LASIK procedure requires the use of a commercially available
> microkeratome that has been cleared for marketing via premarket
> notification. The device used in this study consists of a
> sterilization/storage tray, which includes the shaper head, a
> left/right eye adapter, suction ring, suction handle, blade handling
> pin, and corneal reference marker. The instrument motor, tonometer,
> cleaning brush, disposable blades, power/suction supply unit with
> vacuum and motor footswitches and power cords are provided as separate
> components in an accessory stand and equipment suitcase which complete
> the system.

**VI. [ALTERNATIVE PRACTICES AND PROCEDURES]{.underline}**

> Conventional methods in correcting nearsightedness with and without
> astigmatism are: spectacles, contact lenses, PRK, or other types of
> refractive surgery.

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

> Over 150 LSX have been installed in the following countries:
>
> Argentina Costa Rica India Norway The Netherlands
>
> Australia Dom. Republic Israel Pakistan Turkey
>
> Belgium Egypt Italy Peru Yugoslavia
>
> Brazil England Korea Portugal
>
> Canada Finland Malaysia Romania
>
> China France Mexico South Africa
>
> Columbia Guatemala Namibia Spain
>
> The LSX has not been withdrawn from marketing for any reason relating
> to the safety and effectiveness of the device.

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

> Potential adverse effects associated with LASIK include: loss of best
> spectacle corrected visual acuity, overcorrection, increase in
> refractive cylinder, abnormal glare, double vision, sensitivity to
> bright lights, difficulty with night vision, increase in intraocular
> pressure, corneal haze, corneal infection/ulcer/infiltrate, corneal
> decompensation/edema, lens abnormality and secondary surgical
> intervention, problems associated with the flap, including a lost,
> misplaced or misaligned flap, retinal detachment, and retinal vascular
> accidents.
>
> Please refer to the complete listing of adverse events and
> complications observed during the clinical study, which are presented
> in the clinical study section.
>
> **IX. [SUMMARY OF PRECLINICAL STUDIES]{.underline}**
>
> No additional preclinical studies were required for the use of the
> device for LASIK. Please refer to the SSED of the original PMA
> P980008.

**X. [SUMMARY OF CLINICAL STUDY]{.underline}**

> The sponsor performed a prospective clinical trial in healthy eyes at
> ten US clinical sites under investigational device exemption (IDE)
> application \# G980248. The data from this study served as the basis
> for the approval decision. Specifically, safety and effectiveness
> outcomes at 6 months postoperatively were assessed, as stability was
> reached by that time. Outcomes at 12 months postoperatively were also
> evaluated for confirmation of stability. The IDE study is described in
> detail as follows:

A.  Study Objectives

> The objectives of the study were to determine the safety and
> effectiveness of the LSX for LASIK treatment of spherical equivalent
> refraction (SER) of up to -15.00 D (--0.50 to --15.00 D of myopia with
> and without astigmatism of --0.50 to --6.00 D) and to assess stability
> of the achieved visual outcome.

##### Study Design

The study was a prospective, non-randomized, 10 center, and 23 surgeon
study where the primary control was the preoperative state of the
treated eye (i.e., comparison of pretreatment and post-treatment visual
parameters in the same eye).

C.  Inclusion and Exclusion Criteria

###### Study subjects were 18 years or older and had signed an informed consent. Enrollment occurred if the subject met these conditions: -0.50 to --15.00 D SER and spherical myopia with astigmatism up to 6 D; best spectacle corrected visual acuity (BSCVA) of 20/25 or better in the operative eye, normal corneal topography and stable manifest refraction as documented by [\<]{.underline} 0.5 D change or [\<]{.underline} 10% of (SER) shift within twelve months prior to surgery. Contact lens wearers had to refrain from contact lens use prior to baseline examination (2 weeks for soft / gas permeable lenses, 3 weeks for hard lenses). 

> Subjects not meeting the above inclusion criteria were excluded from
> the study. In addition, subjects who exhibited any of the following
> conditions were excluded: keratoconus, active ocular disease or
> corneal abnormality, corneal neovascularization within 1 mm of the
> intended ablation zone, systemic disease likely to affect wound
> healing, unstable keratometry readings with irregular shaped mires or
> corneascope photographs with broken central rings, use of systemic
> medications likely to affect wound healing,immunodeficiency, previous
> intraocular or corneal surgery, glaucoma or glaucoma suspect, corneal
> thickness that would require ablation within 250 microns of
> endothelium, sensitivity to study medications, pregnancy/lactation,
> and participation in another ophthalmic trial within the past 30 days.

####### Study Plan, Patient Assessments and Efficacy Criteria

> Subjects were evaluated preoperatively and postoperatively at day and
> week one and at months 1, 3, 6, and 12. Pre-operative objective
> measurements included: uncorrected and best corrected visual acuity,
> manifest or cycloplegic refraction, keratometry, intraocular pressure,
> pachymetry, clinical assessment of corneal clarity, clinical
> assessment of anterior chamber, vitreal, retinal and lens status,
> assessment of complications and adverse reactions, and assessment of
> pupil size in mesopic (dim) conditions.
>
> Additionally, corneal topography was performed pre-operatively to rule
> out corneal abnormalities, such as keratoconus.
>
> Subjects were permitted to have second eyes (fellow eyes) treated at
> the same time as the first eye (primary eye). In addition, subjects
> were eligible for retreatment if the treated eye remained
> undercorrected and /or regression decreased the uncorrected vision to
> 20/30 or worse and the eye had a stable refraction.
>
> Effectiveness was evaluated based on improvement in uncorrected visual
> acuity, reduction in mean spherical equivalent refractive error, and
> stability of refractive outcome through the postoperative period, and
> in terms of accuracy of correction. Descriptive statistics were
> provided on data up to 6 months.
>
> The primary efficacy variables for this study were improvement of UCVA
> and accuracy of manifest refraction spherical equivalent (MRSE).

D.  Study Period, Investigational Sites and Demographic Data

```{=html}
<!-- -->
```
1.  Study Period

> A total of 204 eyes in 109 subjects were treated between August 17,
> 1999 and June 20, 2000. The database for this PMA supplement reflected
> the data collected through June 30, 2000.

2.  Demographics and Baseline Characteristics

> The demographics of this study population are very typical of a
> contemporary refractive surgery trial performed in the US. The cohort
> consists primarily of Caucasians. The majority of subjects were male.
> The mean age was 39.8 years at the time of surgery. Preoperative
> patient characteristics that were found to associate with outcomes are
> discussed in section X.F.2.f (Factors Associated with Outcomes).

+-----------------------------------+----------------------------------+
| Table 1                           |                                  |
|                                   |                                  |
| Demographic Characteristics       |                                  |
|                                   |                                  |
| 109 subjects (204 eyes)           |                                  |
+-----------------------------------+----------------------------------+
|                                   | #########                        |
|                                   |                                  |
|                                   | ######### 109 subjects           |
|                                   |                                  |
|                                   | ######### (204 eyes)             |
+-----------------------------------+----------------------------------+
| ######### Male                    | 60                               |
+-----------------------------------+----------------------------------+
| ######### Female                  | 49                               |
+-----------------------------------+----------------------------------+
| ######### Race                    |                                  |
+-----------------------------------+----------------------------------+
| #########  Caucasian              | 101                              |
+-----------------------------------+----------------------------------+
| #########  Hispanic               | 2                                |
+-----------------------------------+----------------------------------+
| #########  Asian                  | 3                                |
+-----------------------------------+----------------------------------+
| #########  Black                  | 3                                |
+-----------------------------------+----------------------------------+
| ######### Contact Lens History    |                                  |
+-----------------------------------+----------------------------------+
| None                              | 85                               |
+-----------------------------------+----------------------------------+
| #########  Soft                   | 107                              |
+-----------------------------------+----------------------------------+
| #########  RGP                    | 12                               |
+-----------------------------------+----------------------------------+
| #########  PMMA                   | 0                                |
+-----------------------------------+----------------------------------+
| ######### Mean Age                | 39.8                             |
|                                   |                                  |
| ######### (Range)                 | 20- 68                           |
+-----------------------------------+----------------------------------+

+-----------------------------------+----------------------------------+
|                                   |                                  |
+-----------------------------------+----------------------------------+
| []{.mark}                         | #########                        |
|                                   |                                  |
|                                   | #########                        |
|                                   |                                  |
|                                   | #########                        |
+-----------------------------------+----------------------------------+
| #########                         |                                  |
+-----------------------------------+----------------------------------+
| #########                         |                                  |
+-----------------------------------+----------------------------------+
| #########                         |                                  |
|                                   |                                  |
| #########                         |                                  |
+-----------------------------------+----------------------------------+

##### F. Data Analysis and Results

1.  Baseline Characteristics

> Table 2 contains a summary of the preoperative refractive errors of
> the entire cohort. Note that the evaluation of the effectiveness (see
> section 2e. below) concerns the subset of eyes with treatment less
> than 6.0 diopters spherical equivalent refraction (SER). Baseline
> characteristics were as follows:

+----------------------------------+-----------------------------------+
| #########                        |                                   |
+----------------------------------+-----------------------------------+
|                                  |                                   |
+----------------------------------+-----------------------------------+

2.  

+-----------------------------------+----------------------------------+
| Table 2                           |                                  |
|                                   |                                  |
| #                                 |                                  |
| ######## Baseline Characteristics |                                  |
|                                   |                                  |
| All Eyes (N=204)                  |                                  |
+-----------------------------------+----------------------------------+
| Spherical equivalent refraction   | Number (%)                       |
|                                   |                                  |
| (SER)                             |                                  |
+-----------------------------------+----------------------------------+

> 2\. Postoperative Characteristics and Results

a.  Patient Accountability

> There were 210 eyes enrolled and 204 eyes treated. Accountability for
> all eyes treated was 86.8% at month 3 and 84.2% at month 6. This
> surpasses the 80% benchmark. The following cohorts were used for
> analysis:

-   Safety---all eyes (N=204)

-   Effectiveness---eyes with treatment of -0.5 to less than -6.0
    diopters SER (N=183)

    Stability---subset of all eyes seen at any two consecutive visits,
    and subset of all eyes seen at all visits (1,3,6 and 12 months)

######### 

  --------------------------------- --------- --------- ---------- ---------- ----------
                                    **1       **1       **3        **6        **12
                                    Week**    Month**   Months**   Months**   Months**

  **Available for Analysis n/N      195/ 204  192/ 204  177/ 204 ( 123/ 204 ( 92/ 204 (
  (%)**                             ( 95.6%)  ( 94.1%)  86.8%)     60.3%)     45.1%)

  **Not yet due for the interval    0/ 204 (  0/ 204 (  0/ 204 (   43/ 204 (  45/ 204 (
  n/N (%)**                         0.0%)     0.0%)     0.0%)      21.1%)     22.1%)

  **Lost to Follow-up n/N (%)**     0/ 204 (  0/ 204 (  0/ 204 (   1/ 204 (   10/ 204 (
                                    0.0%)     0.0%)     0.0%)      0.5%)      4.9%)

  **Discontinued n/N (%)**          0/ 204 (  0/ 204 (  0/ 204 (   15/ 204 (  28/ 204 (
                                    0.0%)     0.0%)     0.0%)      7.4%)      13.7%)

  **Missed Visit n/N (%)**          9/ 204 (  12/ 204 ( 27/ 204 (  22/ 146 (  50/ 131 (
                                    4.4%)     5.9%)     13.2%)     26.0%)     67.2%)

  **% Accountability =**                                                      

  **[\_\_\_\_\_\_\_Available for                                              
  Analysis                                                                    
  \_\_\_\_\_\_\_\_]{.underline}**                                             

  **(Enrolled** **--**              195/ 204  192/ 204  177/ 204 ( 123/ 146 ( 92/ 131 (
  **Discontinued** **--** **Not yet ( 95.6%)  ( 94.1%)  86.8%)     84.2%)     70.2%)
  due)**                                                                      

                                                                              

  N = Total eyes treated                                                      
  --------------------------------- --------- --------- ---------- ---------- ----------

b.  Stability of Outcome

> In the 3-6 month window, greater than 95% of eyes experienced a change
> of MRSE not exceeding 1.0 D. Furthermore, the mean of the
> paired-difference of MRSE progressively decreased over time, and
> reached a change of less than 0.02 D in the 3-6 months window (Tables
> 4 to 5). The changes in the 6-12 months window for the entire cohort
> remained at less than 0.05 D; thus, stability was demonstrated by 6
> months postoperative.

+----------------+-----------------+-----------------+----------------+
| > Table 4      |                 |                 |                |
| >              |                 |                 |                |
| > Stability of |                 |                 |                |
| > Manifest     |                 |                 |                |
| > Refraction   |                 |                 |                |
| >              |                 |                 |                |
| > (Eyes with   |                 |                 |                |
| > two          |                 |                 |                |
| > consecutive  |                 |                 |                |
| > visits       |                 |                 |                |
| > through 12   |                 |                 |                |
| > Months)      |                 |                 |                |
+----------------+-----------------+-----------------+----------------+
| Change in      | 1 and 3 Months  | 3 and 6 Months  | 6 and 12       |
| Spherical      |                 |                 | Months         |
| Equivalent     | n/N (%)         | n/N (%)         |                |
|                |                 |                 | n/N (%)        |
+----------------+-----------------+-----------------+----------------+
| [\             | 164/168 (97.6)  | 103/106 (97.2)  | 79/79 (100.0)  |
| <]{.underline} |                 |                 |                |
| 1.00 D         |                 |                 |                |
+----------------+-----------------+-----------------+----------------+
| Mean           | -0.13           | -0.02           | 0.03           |
| Difference     |                 |                 |                |
+----------------+-----------------+-----------------+----------------+
| SD             | 0.37            | 0.42            | 0.38           |
+----------------+-----------------+-----------------+----------------+
| 95% CI (Mean)  | (-0.15, -0.11)  | ( -0.05, 0.01)  | (-0.00,0.06)   |
+----------------+-----------------+-----------------+----------------+

+----------------+-----------------+-----------------+----------------+
| > Table 5      |                 |                 |                |
| >              |                 |                 |                |
| > Stability of |                 |                 |                |
| > Manifest     |                 |                 |                |
| > Refraction   |                 |                 |                |
| >              |                 |                 |                |
| > Eyes that    |                 |                 |                |
| > had every    |                 |                 |                |
| > exam through |                 |                 |                |
| > 12 Months    |                 |                 |                |
+----------------+-----------------+-----------------+----------------+
| Change in      | 1 and 3 Months  | 3 and 6 Months  | 6 and 12       |
| Spherical      |                 |                 | Months         |
| Equivalent     | n/N (%)         | n/N (%)         |                |
| Between        |                 |                 | n/N (%)        |
+----------------+-----------------+-----------------+----------------+
| [\             | 71/72 (98.6)    | 70/72 (97.2)    | 72/72 (100.0)  |
| <]{.underline} |                 |                 |                |
| 1.00 D         |                 |                 |                |
+----------------+-----------------+-----------------+----------------+
| Mean           | -0.11           | 0.02            | 0.05           |
| Difference     |                 |                 |                |
+----------------+-----------------+-----------------+----------------+
| SD             | 0.35            | 0.37            | 0.38           |
+----------------+-----------------+-----------------+----------------+
| 95% CI (Mean)  | (-0.14, -0.08)  | (-0.01, 0.05)   | (0.02, 0.08)   |
+----------------+-----------------+-----------------+----------------+

> c\. Effectiveness Outcomes
>
> The analysis of effectiveness was based on the 111 eyes evaluable at
> the 6 month stability timepoint for the cohort of subjects with
> preoperative SER of -0.5 to less than -6.0 D. This analysis includes
> eyes where the cylinder treatment differed from the full preoperative
> cylinder. In the cohort of all eyes, this difference was \> 0.25 D in
> 11 eyes. Key efficacy outcomes over the course of the study and at the
> point of stability stratified by diopter of MRSE are presented in
> tables 6 and 7. At 6 months, 93.5% of eyes had UCVA 20/40 or better
> and 49.5% of eyes had UCVA 20/20 or better.
>
> Treatments for nearsightedness without astigmatism resulted in
> undercorrection for some eyes. In the clinical study, for eyes with
> preoperative SER \< 7 D, 24% of eyes without preoperative astigmatism
> were undercorrected by more than 1.0 D at 6 months.
>
> In the clinical study, the number of eyes treated for 6.0 diopters and
> greater SER were few, and these eyes had reduced effectiveness and
> stability outcomes; therefore these data do not support effectiveness
> of the LSX system for the higher treatment range and are not presented
> here. No clinical data were presented for any eye with a preoperative
> cylinder \> 4.5 D.

  ----------------- ------- --------- --------- --------- --------- --------- -----------
                                                                              

                    **\<    **-1.0    **-2.0    **-3.0    **-4.0    **-5.0    **CUM**
                    -1.0    to**      to**      to**      to**      to**      
                    D**                                                       

                    ** **   **-1.99   **-2.99   **-3.99   **-4.99   **-5.99   **TOTAL**
                            D**       D**       D**       D**       D**       

                    ** **   ** **     ** **     ** **     ** **     ** **     **\< 6 D**

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

  **Efficacy                                                                   
  Variables**                                                                 

  UCVA 20/20 or     3/3     16/29 (   10/20 (   8/17 (    13/25 (   3/13 (    53/107 (
  better\*          (100)   55)       50)       47)       52)       23)       50)

  UCVA 20/40 or     3/3     29/29     20/20     15/17 (   22/25 (   11/13 (   100/107 (
  better\*          (100)   (100)     (100)     88)       88)       85)       93)

  MRSE              1/3 (   23/30 (   13/20 (   11/19 (   15/26 (   9/13 (    72/111 (
  [+]{.underline}   33)     77)       65)       58)       58)       69)       65)
  0.50 D                                                                      

  MRSE              3/3     29/30 (   19/20 (   16/19 (   21/26 (   10/13 (   98/111 (
  [+]{.underline}   (100)   97)       95)       84)       81)       77)       88)
  1.00 D                                                                      

  MRSE              3/3     30/30     20/20     18/19 (   25/26 (   13/13     109/111 (
  [+]{.underline}   (100)   (100)     (100)     95)       96)       (100)     98)
  2.00 D                                                                      

                                                                              

  \* For all eyes                                                             
  minus those                                                                 
  treated for                                                                 
  monovision.                                                                 
  ----------------- ------- --------- --------- --------- --------- --------- -----------

+-----------------------------------+----------------------------------+
|                                   |                                  |
+-----------------------------------+----------------------------------+
|                                   | #########                        |
|                                   |                                  |
|                                   | #########                        |
+-----------------------------------+----------------------------------+
| #########                         |                                  |
+-----------------------------------+----------------------------------+
|                                   |                                  |
+-----------------------------------+----------------------------------+
|                                   |                                  |
+-----------------------------------+----------------------------------+
|                                   |                                  |
+-----------------------------------+----------------------------------+
|                                   |                                  |
+-----------------------------------+----------------------------------+

Analysis of the correction of the cylindrical component of the
astigmatic eyes is presented in Tables 8 and 9. The Ophthalmic Devices
Panel (the Panel), at the January 14, 1997 meeting, assessed outcomes
from a myopic astigmatic treatment and provided FDA with recommendations
as to acceptable effectiveness rates. The 63.2% mean reduction in
absolute cylinder at 6 months is consistent with what the Panel
considered acceptable mean reduction in absolute cylinder at the point
of stability.

+------------------------------+---------------------------------------+
| **Table** **8**              |                                       |
|                              |                                       |
| **Cylinder Correction        |                                       |
| Efficacy Stratified by       |                                       |
| Pre-Operative Cylinder**     |                                       |
|                              |                                       |
| **(N=88)**                   |                                       |
+------------------------------+---------------------------------------+
|                              | **6 Months**                          |
+------------------------------+---------------------------------------+
| **Pre-Operative Cylinder**   | **Reduction of Absolute Cylinder**    |
+------------------------------+---------------------------------------+

> Looking at intended versus achieved vector magnitude cylinder, the
> Intended Refractive Correction ("IRC") had a mean of 1.50 D with a
> median of 1.25 D (range --1.50 to 4.50 D). The Surgically Induced
> Refractive Correction ("SIRC") had a mean of 1.41 D with a median of
> 1.00 D (range --1.50 to 5.50 D). The vector magnitude ratio (SIRC/IRC)
> was 0.77 at 6 months. The Panel has found 0.82 acceptable for
> correction efficacy (SIRC/IRC) at stability.

+------------------------------+---------------------------------------+
| **Table** **9**              |                                       |
|                              |                                       |
| **Cylinder Correction        |                                       |
| Efficacy Stratified by       |                                       |
| Pre-Operative Cylinder**     |                                       |
|                              |                                       |
| **(N=90)**                   |                                       |
+------------------------------+---------------------------------------+
|                              | ######### 6 Months                    |
+------------------------------+---------------------------------------+
| **Pre-Operative Cylinder**   | **Achieved vs Intended Vector         |
|                              | Magnitude Ratio (Achieved/Intended)   |
|                              | Mean**                                |
+------------------------------+---------------------------------------+
| [\<]{.underline} 1.0D        | > 0.62                                |
+------------------------------+---------------------------------------+
| \> 1.0 to [\<]{.underline}   | > 0.82                                |
| 2.0D                         |                                       |
+------------------------------+---------------------------------------+
| \> 2.0 to [\<]{.underline}   | > 0.98                                |
| 3.0D                         |                                       |
+------------------------------+---------------------------------------+
| \> 3.0 to [\<]{.underline}   | > 1.03                                |
| 4.0D                         |                                       |
+------------------------------+---------------------------------------+
| \> 4.0 to [\<]{.underline}   | > 1.04                                |
| 4.5D                         |                                       |
+------------------------------+---------------------------------------+
| Total                        | > 0.77                                |
+------------------------------+---------------------------------------+

  -------------- ------------------ ---------------- ---------------------
                                                     

                                                     

                                                     

                                                     

                                                     

                                                     
  -------------- ------------------ ---------------- ---------------------

> d\. Key Safety Results
>
> The analysis of safety was based on the cohort of all 204 eyes treated
> in the clinical study. Safety was evaluated based on maintenance of
> BSCVA, surgical induction of additional refractive cylinder, and
> adverse events and complications. Table 10 presents a summary of key
> safety variables for all eyes treated at the 1, 3 and 6 month visits.
> The proportion of eyes at 1 month with a BSCVA worse than 20/25 if
> 20/20 or better preoperatively was 2.1%. No eyes were reported to have
> a BSCVA worse than 20/40 or a loss of \>2 lines of BSCVA at any visit.

+-----------------------+----------------+-----------+----------------+
| Table 10              |                |           |                |
|                       |                |           |                |
| Summary of Key Safety |                |           |                |
| Variables Over Time   |                |           |                |
|                       |                |           |                |
| (all eyes treated)    |                |           |                |
+-----------------------+----------------+-----------+----------------+
| Safety                | 1 Month        | 3 Months  | 6 Months       |
|                       |                |           |                |
| Variable              | N= 192         | N= 174    | N=123          |
|                       |                |           |                |
|                       | n (%)          | n (%)     | n (%)          |
+-----------------------+----------------+-----------+----------------+
| Loss of \>2 lines     | 0 (0.0)        | 0 (0.0)   | 0 (0.0)        |
| BSCVA.                |                |           |                |
+-----------------------+----------------+-----------+----------------+
| Loss of               | 4 (2.1)        | 1 (0.6)   | 1 (0.8)        |
| [\>]{.underline} 2    |                |           |                |
| Lines BSCVA           |                |           |                |
+-----------------------+----------------+-----------+----------------+
| BSCVA worse than      | 0 (0.0)        | 0 (0.0)   | 0 (0.0)        |
| 20/40.                |                |           |                |
+-----------------------+----------------+-----------+----------------+
| Increase of \> 2D     | 0/52 (0.0)     | 0/44      | 0/33 (0.0)     |
| cylinder#             |                | (0.0)     |                |
+-----------------------+----------------+-----------+----------------+
| BSCVA worse than      | 4 (2.1)        | 0 (0.0)   | 0 (0.0)        |
| 20/25 if 20/20 or     |                |           |                |
| better preoperatively |                |           |                |
+-----------------------+----------------+-----------+----------------+

  ----------------------- ----------------- ------------ -----------------
                                                         

                                                         

                                                         

                                                         

                                                         

                                                         
  ----------------------- ----------------- ------------ -----------------

  ----------------------- ----------------- ------------ -----------------
                                                         

                                                         

                                                         

                                                         

                                                         

                                                         
  ----------------------- ----------------- ------------ -----------------

> Tables 11 and 12 summarize adverse events and complications
> experienced following LASIK treatment of myopia with and without
> astigmatism for all eyes. The benchmark for each adverse event (Table
> 11) is a rate of less than 1% per event. There were no adverse events
> at a rate over 1%. With regard to complications, 2.8% had epithelial
> ingrowth. Overall, the device was deemed reasonably safe.

# 

  -------------------------------- ------- ----- ------- ----- ------- -----
  Retinal vascular accidents       0/202   0.0   0/204   0.0   0/143   0.0

  -------------------------------- ------- ----- ------- ----- ------- -----

#  

# 

# 

# 

# 

# 

# 

# 

# 

# 

# 

# 

# 

# 

# 

# 

# 

# 

# 

# 

# e. Retreatment

# 

> Fourteen eyes were retreated with the study laser due to
> undercorrection and/or regression. Table 13 contains the outcomes of
> the retreated eyes. There were insufficient data to form definitive
> conclusions regarding the safety and effectiveness of retreatment with
> this device.

  -------------------------- -------------- -------------- ---------- --------- -- --
                             **1 Month**    **3 Months**   **6                     
                                                           Months**                

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

  **Efficacy Variables**                                                           

  UCVA 20/20 or better\*     13/14 (92.9)   8/10 (80.0)    \-\--                   

  UCVA 20/40 or better\*     14/14 ( 100)   10/10 ( 100)   \-\--                   

  MRSE [+]{.underline} 0.50  11/13 (84.6)   10/11 (90.9)   \-\--                   
  D                                                                                

  MRSE [+]{.underline} 1.00  13/13 ( 100)   10/11 (90.9)   \-\--                   
  D                                                                                

  MRSE [+]{.underline} 2.00  13/13 ( 100)   11/11 ( 100)   \-\--                   
  D                                                                                

  **Safety Variables**                                                             

  Loss of [\>]{.underline} 2 0/13 ( 0.0)    0/11 ( 0.0)    \-\--                   
  lines BSCVA                                                                      

  BSCVA worse than 20/40     0/13 ( 0.0)    0/11 ( 0.0)    \-\--                   

  Increase of \> 2 D         0/3 (0.0)      0.3 (0.0)      \-\--                   
  cylinder^\#^                                                                     

  BSCVA worse than 20/25 if  0/13 ( 0.0)    0/11 ( 0.0)    \-\--                   
  20/20 or better                                                                  
  preoperatively                                                                   

                                                                                   

  \*For all eyes minus those                                                       
  intentionally treated for                                                        
  monovision.                                                                      

  \# For eyes treated for                                                          
  spherical correction only.                                                       
  -------------------------- -------------- -------------- ---------- --------- -- --

> f\. Factors Associated with Outcomes
>
> Table 14 displays results of the testing for association between
> several baseline characteristics and 6 month outcomes. A significant
> association between patient age and the proportion of eyes with UCVA
> 20/20 or better was found (p=0.0022, Fisher's Exact test). Similarly,
> patient age was associated with the proportion of eyes within 1 D of
> intended MRSE (p=0.0364). In both cases, patients with ages at the
> median (39.7 years) or younger had significantly better visual acuity
> and refractive outcomes at 6 months, than patients above the median
> age. No other significant associations between patient gender, race or
> contact lens wear were found.

  -------------------------- ----------------- --------------------------
  **Pre-Operative            **UCVA 20/20      **MRSE Within 1 D of
  Dichotomous Factor**       p-Value**         Intended p-Value**

  Gender (M/F)               0.8599            0.2051

  Age ([\<]{.underline} 39.7 0.0022            0.0364
  or \> 39.7)^2^                               

  Race (White or Non-White)  1.0000            1.0000

  Contact Lens Wear (Yes/No) 0.1101            0.2054

                                               

  1\. Association between                      
  preoperative factor and                      
  outcome determined by                        
  results of Fisher\'s                         

  Exact test (2x2 table).                      

  2\. Median age                               
  -------------------------- ----------------- --------------------------

g.  
h.  
i.  

  --------------------- --------- --------- --------- --------- ---------
                                                                

                                                                
  --------------------- --------- --------- --------- --------- ---------

g.  Patient Symptoms

> In the clinical study, before and 6 months after surgery patients were
> asked to rate a series of subjective events. The percentage of
> patients that rated each condition as "often" or "always"
> preoperatively and at 6 months is listed below in Table 15.

  --------------------- ------------- ------------ ------------- ------------
  PATIENT SYMPTOMS      Eyes Without               Eyes With     
                        astigmatism                astigmatism   

                        **PREOP**     **6 MO**     **PREOP**     **6 MO**

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

  Foreign Body          0/52 (0.0)    2/24 (8.3)   3/144 (2.1)   5/55 (9.1)
  Sensation                                                      

  Burning Feeling       1/52 (1.9)    0/24 (0.0)   5/144 (3.5)   3/55 (5.5)

  Watery Eyes           5/52 (9.6)    0/24 (0.0)   9/144 (6.3)   3/55 (5.5)

  Halos/Starbursts      5/52 (9.6)    3/24 (12.5)  18/144 (12.5) 2/55 (3.6)

  Double Vision         0/52 (0.0)    0/23 (0.0)   1/144 (0.7)   0/54 (0.0)

  Clarity Changes       5/52 (9.6)    7/24 (29.2)  9/144 (6.3)   5/55 (9.1)

  Night Vision Problems                                           

  While Driving         12/52 (23.1)  9/24 (37.5)  40/144 (27.8) 14/55 (25.5)
  --------------------- ------------- ------------ ------------- ------------

> h\. Patient Satisfaction
>
> Subjects were asked to rate their satisfaction with the surgery on a
> scale of 1-10, 1 "being very disappointed" and 10 "being very
> satisfied". The results of the questionnaire are listed below:

  --------------------- --------- ---------- ------------ --------- -----------
  ** **                 **N**     **Mean**   **Median**   **Std**   **Range**

  **Patient             77        8.7        10           2         3.0 - 10.0
  Satisfaction (1-10)**                                             
  --------------------- --------- ---------- ------------ --------- -----------

**XI. [CONCLUSIONS DRAWN FROM THE STUDIES]{.underline}**

> The data in this application support reasonable assurance of the
> safety and effectiveness of this device when used in accordance with
> the approved indications for use.

**XII. [PANEL RECOMMENDATIONS]{.underline}**

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

**XIII. [FDA DECISION ]{.underline}**

> CDRH issued a major deficiency letter to LaserSight Technologies on
> March 15, 2001. In amendments received on April 19, May 11, July 10,
> July 12, August 1, and September 4, 2001 LaserSight submitted the
> required changes, clarification and information. The applicant
> addressed all the labeling concerns raised by FDA. CDRH issued an
> approval order on September 28, 2001.

**XIV.** **[APPROVAL SPECIFICATIONS]{.underline}**

> Directions for Use: See Device Labeling.
>
> Hazards to health from use of the device: See Indications,
> Contraindications, Warnings, Precautions and Adverse Events in the
> labeling.

10. 
11.