IntraLase Enabled Keratoplasty

The IntraLase femtosecond lasers are the first in the world used to create innovative shaped corneal incisions for full-thickness corneal transplants. The ultra-fast femtosecond lasers allow the surgeon to create precisely shaped incisions that enable the tissue to fit together much like puzzle pieces do. Clinical data validate that the optimized wound architecture provides for a more stable graft that requires minimal sutures and speeds patient healing and visual recovery.⁹

• Provides a smooth corneal contour immediately following surgery
• Preserves corneal optics — less distortion
• Reduces the risk of induced astigmatism
• Promotes more rapid restoration of functional vision

IntraLase Enabled Lamellar Keratoplasty (IELK)

IELK is a safe, effective and minimally invasive technique:

• In a retrospective study of 12 consecutive eyes with anterior corneal scarring, no intraoperative complications were found¹¹
• The IntraLase FS laser empowers the surgeon to custom design incisions for individualized Anterior Lamellar Keratoplasty (ALK)
• Precise fit between the donor tissue and the recipient cornea results in faster, better wound healing and enables sutureless ALK¹¹

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, 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.

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.