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Laser assisted in-situ keratomileusis (LASIK) can only be performed by a trained ophthalmologist and for specified 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. Patients are requested to consult with their 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.

The IntraLase FS and iFS Laser Systems are ophthalmic surgical lasers indicated for use in patients undergoing surgery or treatment requiring the initial lamellar resection of the cornea, in the creation of a lamellar cut/resection of the cornea for lamellar IntraLase-Enabled Keratoplasty (IEK), in the creation of a penetrating cut/incision for penetrating IEK, penetrating and intrastromal arcuate incisions (iFS Laser Only) and for corneal harvesting. Initial lamellar resection contraindications may include cornea edema, glaucoma, and keratoconus. Initial lamellar resection risks and complications may include corneal pain, flap tearing, and epithelial ingrowth. IEK contraindications may include any corneal opacity adequately dense to obscure visualization of this iris, descemetocoele with impending corneal rupture, previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape, and cornea thickness requirements that are beyond the range of the system. Patients are requested to consult with their eye care professional for a complete listing of the contraindications and risks. 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 professional.

©2012 Abbott Medical Optics Inc. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott Laboratories, except to identify the product or services of the company. Accutane is a trademark of Hoffman-LaRoche Inc. Cordarone is a trademark of Sanofi-Synthelabo, Inc.

2011.07.07-RF3706 2012.03.21-RF4943