IntraLase Method

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Important Safety
Summary of Important Safety Information:

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.

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