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
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