Eyeworld

iFS is a trademark owned by or licensed to Abbott Laboratories, its subsidiaries or af liates. ©2014 Abbott Medical Optics Inc. Santa Ana, CA 92705 2013.03.11-RF6551 Contact your AMO representative or visit www.amo-ilasik.com/iFS. Contact your AMO representative or visit DO EVEN MORE WITH PROVEN iFS TECHNOLOGY A comprehensive platform of surgical capabilities As the leader in femtosecond technology with over 5 million procedures worldwide, the iFS Laser goes well beyond LASIK aps to enable the creation of fully individualized incisions for all ophthalmic procedures, including refractive, corneal, and cataract surgery. INDICATIONS: The iFS Laser is a precision ophthalmic surgical laser indicated for use in patients undergoing surgery or treatment requiring initial lamellar resection of the cornea and to create tunnels for placement of corneal ring segments, in lamellar keratoplasty and corneal harvesting, in the creation of a corneal ap in patients undergoing LASIK surgery, and in the creation of a lamellar cut / resection of the cornea for lamellar keratoplasty (IntraLase-Enabled Keratoplasty or IEK), and in the creation of a penetrating cut/incision for penetrating keratoplasty (or IEK). The iFS Laser is also indicated for use in penetrating and/or intrastromal arcuate incisions. CONTRAINDICATIONS: Lamellar resection for the creation of a corneal ap is contraindicated in the presence of corneal edema, corneal lesions, hypotony, glaucoma, existing corneal implant or keratoconus. IEK procedures and arcuate incisions are contraindicated in the presence of any corneal opacity adequately dense to obscure visualization of the 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, or corneal thickness requirements that are beyond the range of the system. WARNINGS: Check all treatment parameters for accuracy. Setting the posterior depth too deep could result in injury to other ocular structures. Patient Interface disposables should not be reused or resterilized. PRECAUTIONS: A surgeon should have successfully completed one or more training courses before attempting to create a corneal resection. The use of the iFS Laser for IEK procedures or for arcuate incisions is not recommended for certain patients. Please see the Operator's Manual for a complete listing. ADVERSE EVENTS: Possible complications resulting from LASIK ap creation include corneal edema/in ammation, corneal pain, epithelial ingrowth, epithelial defect, infection, photophobia, ap decentration, incomplete ap creation, ap tearing or incomplete lift-off, free cap, in ammation, thin or thick aps, or ap striae. Arcuate incision complications include corneal edema/in ammation, corneal pain, epithelial ingrowth, epithelial defect, infection, photophobia or corneal endothelium perforation. Transient Light Sensitivity Syndrome (TLSS) and Peripheral Light Spectrum (PLS) have been sporadically reported and may occur following LASIK ap creation. TLSS (1% of patients) is characterized by symptoms of mild to severe light sensitivity which manifests between 2 and 6 weeks postoperatively. PLS (.03% of patients) is a temporary phenomenon whereby patients report the perception of a spoke-like spectrum of light in the periphery of their vision. CAUTION: Federal law restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care practitioner who has been trained in the calibration and operation of this device, and who have experience in the surgical treatment and management of refractive errors. 2-10 O&C_EW June 2014-DL_Layout 1 6/3/14 12:09 PM Page 5

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