Conditions of Approval

a) Approval is for LaserSight Technologies, Inc.'s application for the LaserScan LSX® Excimer Laser System to perform photorefractive keratectomy (PRK) for the reduction or elimination of mild to moderate myopia (-1.0 to <-6.0 D) with < 1.0 D astigmatism in patients with documentation of a stable manifest refraction (+ 0.5 D) over the past year; and, in patients who are 18 years of age or older.

b) PRK is an elective procedure with the alternatives including, but not limited to, eyeglasses, contact lenses, radial keratotomy, or automated lamellar keratectomy.

c) Approval of the application is based on a U.S. study of 275 eyes with pre-operative myopia < -6.0 D treated and followed for six months, with 181 of these eyes followed for twelve months or longer. In this study, 20/373 (5.4%) eyes were retreated. Of the 20 retreated eyes, 7 eyes reached the 6 months follow-up visit analysis.

d) The study found that of the treated eyes, excluding data collected after retreatment, and based on refractive data at the > 12 month follow-up examination, 85.37% were corrected to 20/40 or better, and 53.1% were corrected to 20/20 or better without spectacles or contact lenses. For the retreated eyes that had reached the 6 month visit, 100% were corrected to 20/40 or better and 57.1% were corrected to 20/20 or better without spectacles or contact lenses.

e) The study showed that the following adverse events occurred in at least 1% of the subjects at twelve months or greater post-treatment: pre-treatment BSCVA (vision corrected with eyeglasses) 20/20 or better with a post-treatment BSCVA worse than 20/25 (1.1%); moderate corneal haze (1.2%); patient discomfort or pain (1.2%); increased intraocular pressure 6-10 mmHg (1.9%); overcorrections > 1.0 D (4.9%); and undercorrections> 1.0 D (17.9%). Patients rated the following significant subjective adverse events both before treatment and 6 months after treatment; halos, starbursts often or always (13.7% before, 23.4% after treatment); night vision problems present (23.8% before, 24.9% after); clarity changes day to day often or always (3.0% before, 12.1% after), burning, gritty feeling often or always (3.6% before, 8.2% after); and double vision or ghosts often or always (0.6% before, 3.2% after).

f) Long term risks of myopic PRK beyond 12 months have not been studied.

g) This laser is not indicated to correct nearsightedness less than -1.0 D or -6.0 D or greater, or astigmatism more than 1.0 D. It is not indicated for use in procedures other than PRK, as described in the approved Operator's Manual.

Contraindications

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

• Active ocular / systemic infection
• Fuch's corneal dystrophy
• Keratoconous
• Central corneal scars affecting visual acuity
• Autoimmune or immunodeficiency diseases
• Pregnant or nursing women

Patients presenting with the following conditions(s) should be considered for PRK only after careful assessment of the potential risk and benefit to the specific patient:

• Collagen vascular disorders
• Myopia progressing at a rate of greater than 0.5 diopters per year
• Active systemic disease

PRK treatment of myopia from -6.0 to -10.0 D with this device has demonstrated risk of a loss of 2 lines or more of BSCVA approximately ten times that below -6.0 D at > 12 months (5.9% vs. 0.6%). For treatment of myopic sphere between -6.0 and -10.0 D effectiveness is also reduced compared to treatments less than -6.0 D. No safety and effectiveness data above -10.0 D are available.