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8 The WaveLight FS200 Laser System Federal (USA) law restricts this device to sale by, or on the order of, a physician. As with any surgical procedure, there are risks associated with the use of the WaveLight FS200 Femtosecond Laser System. Before treating patients with this device, you should carefully review the Procedure Manual, complete the Physician WaveLight System Certification Course, and discuss the risks associated with this procedure and questions about the procedure with your patients. Indications: The WaveLight FS200 Laser System is indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea; in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; in the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty; and in the creation of a penetrating cut/incision for penetrating keratoplasty and for corneal harvesting. The WaveLight FS200 delivery system is used in conjunction with a sterile disposable Patient Interface, consisting of pre-sterilized suction ring assemblies and pre-sterilized applanation cones, intended for single use. The WaveLight FS200 Laser System should only be operated by, or under the direct supervi- sion of, a trained physician with certification in laser safety and in the use of the WaveLight FS200 Laser. Contraindications: LASIK treatments are contraindicated in: Pregnant or nursing women; patients with a diagnosed collagen vascular, autoimmune or immunodeficiency disease; and patients who are taking one or both of the following medications: isotretinoin (Accutane 1 ), amiodarone hydrochloride (Cordarone 2 ). Flap contraindications: Lamellar resection for the creation of a corneal flap using the WaveLight FS200 laser is contraindicated if any of the following conditions exist. Potential contraindications are not limited to those included in this list: corneal edema; corneal lesions; hypotony; glaucoma; existing corneal implant; and keratoconus. Keratoplasty contraindications: Penetrating cut/incision (for penetrating keratoplasty) is contraindicated in: any corneal opacity adequately dense to obscure visualization of the iris; descemetocoete with impending corneal rupture; previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape; and corneal thickness requirements that are beyond the range of the System. Other considerations: The following conditions should also be considered: severe corneal thinning; subjects with pre-existing glaucoma; a history of steroid responsive rise in intraocular pressure; preoperative intraocular pressure greater than 21 mm Hg in the operative eye; subjects with more than 1000 μm corneal thickness at the 9 mm peripheral zone; active intraocular inflammation; and active ocular infection. Complications: Possible complications which may result from flap cutting include (potential complications are not limited to those included in this list): corneal edema; corneal pain; epithelial ingrowth; epithelial infection; flap decentration; incomplete flap creation; flap tearing or incom- plete lift-off; free cap; photophobia; corneal inflammation, such as diffuse lamellar keratitis (DLK), corneal infiltrates and iritis; thin or thick flaps; flap striae; and corneal ectasia (secondary kerato- conus). Warnings: Any treatment with the WaveLight FS200 is not recommended in patients who have: systemic diseases likely to affect wound healing, such as connective tissue disease, insulin dependent diabetes, severe atopic disease or an immunocompromised status; a history of Herpes simplex or Herpes zoster keratitis; significant dry eye that is unresponsive to treatment; severe allergies; and a history of glaucoma or ocular hypertension. We recommend discussing the following potential complications of this device with your patients: Transient Light Sensitivity Syndrome (TLSS): Transient Light Sensitivity Syndrome is char- acterized by symptoms of mild to severe light sensitivity that manifests between two and six weeks postoperatively. Patients experience no decrease in uncorrected or best spectacle-corrected visual acuity. The incidence of this sensitivity was observed in approximately 1% of patients who un- dergo flap creation with a femtosecond laser. 3 Patients respond to the use of hourly topical steroids such as Pred Forte (Allergan), and most report improvement within one week of treatment. Peripheral Light Spectrum (PLS): Peripheral Light Spectrum is a temporary phenomenon whereby patients report the perception of a spoke-like spectrum of light in the periphery of their vision. PLS has no clinical examination findings and no effect on visual acuity; however the potential diffractive effects may be bothersome to some patients. Reported in only a small amount of cases, the onset of symptoms occurs during the immediate postoperative period, and typically resolves within three months but may be slightly persistent in rare cases. The visual impact of PLS is clinically inconsequential for the vast majority of patients. 1. Accutane is a registered trademark of Hoffmann-La Roche Inc. 2. Cordarone is a registered trademark of Sanofi. 3. FDA Database Research Results Feb. 05, 2009. LenSx Laser Caution United States Federal Law restricts this device to sale and use by or on the order of a physician or licensed eyecare practitioner. Indication The LenSx Laser is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmenta- tion, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. Restrictions • Patients must be able to lie flat and motionless in a supine position. • Patients must be able to understand and give an informed consent. • Patients must be able to tolerate local or topical anesthesia. • Patients with elevated IOP should use topical steroids only under close medical supervision. Contraindications • Corneal disease that precludes applanation of the cornea or transmission of laser light at 1030 nm wavelength • Descemetocele with impending corneal rupture • Presence of blood or other material in the anterior chamber • Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the capsulotomy • Conditions that would cause inadequate clearance between the intended capsulotomy depth and the endothelium (applicable to capsulotomy only) • Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape • Corneal thickness requirements that are beyond the range of the system • Corneal opacity that would interfere with the laser beam • Hypotony or the presence of a corneal implant • Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease) • History of lens or zonular instability • Any contraindication to cataract or keratoplasty • This device is not intended for use in pediatric surgery. Warnings The LenSx Laser System should only be operated by a physician trained in its use. The LenSx Laser delivery system employs one sterile disposable LenSx Laser Patient Interface consisting of an applanation lens and suction ring. The Patient Interface is intended for single use only. The disposables used in conjunction with ALCON instrument products constitute a complete surgical system. Use of disposables other than those manufactured by Alcon may affect system performance and create potential hazards. The physician should base patient selection criteria on professional experience, published litera- ture, and educational courses. Adult patients should be scheduled to undergo cataract extraction. Precautions • Do not use cell phones or pagers of any kind in the same room as the LenSx Laser. • Discard used Patient Interfaces as medical waste. AEs/Complications • Capsulotomy, phacofragmentation, or cut or incision decentration • Incomplete or interrupted capsulotomy, fragmentation, or corneal incision procedure • Capsular tear • Corneal abrasion or defect • Pain • Infection • Bleeding • Damage to intraocular structures • Anterior chamber fluid leakage, anterior chamber collapse • Elevated pressure to the eye Attention Refer to the LenSx Laser Operator's Manual for a complete listing of indications, warnings, and precautions. EW San Francisco 2013 Sunday, April 21, 2013 8 Important safety information MIX13250SOV Alcon Sunday_SF2103 8pages-DL2_Layout 1 4/20/13 8:12 PM Page 8

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