Summary of Safety Information
Laser assisted in-situ keratomileusis (LASIK) can only be performed by a trained physician and is specified for reduction or elimination of myopia, hyperopia, and astigmatism as indicated within the product labeling. Laser refractive surgery is contraindicated for patients: a) with collagen vascular, autoimmune, or immunodeficiency diseases; b) who are pregnant or nursing women; c) with signs of keratoconus or abnormal corneal topography; d) who are taking one or both of the following medications: Isotretinoin (Accutane) and Amiodarone hydrochloride (Cordarone). Potential side effects to laser refractive surgery may include glare, dry eye, as well as other visual anomalies. LASIK requires the use of a microkeratome that cuts a flap on the surface of the cornea, potential side effects may include flap related complications. Consult with your eye care professional and Patient Information Booklet regarding the potential risks and benefits for laser refractive surgery, results may vary for each individual patient.
Restricted Device: U.S. Federal Law restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care practitioner. U.S. Federal Law restricts the use of this device to practitioners who have been trained in its calibration and operation and who have experience in the surgical treatment and management of refractive errors.