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Summary of Important Safety Information - IntraLase® FS and iFS® Laser Systems

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 LASIK may include dry eye, halos, glare, as well as other visual anomalies. LASIK requires the use of a keratome that cuts a flap on the surface of the cornea and may potentially cause inflammation, corneal scratch, epithelial ingrowth, and flap-related complications. Consult the Professional Use Information booklet for a complete listing of contraindications and risk information. Results may vary for each individual patient.

Caution: U.S. Federal law restricts these devices to sale, distribution, and use by or on the order of a licensed eye care practitioner.

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, descemetocele 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.

The product may contain mercury. Please dispose accordingly to state, local or federal laws.