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10 EW Chicago 2012 Monday, April 23, 2012 10 Important safety information EX-PRESS Glaucoma Filtration Device Caution: Federal (U.S.) law restricts this device to sale by, or on the order of, a physician. Indication: The EX-PRESS Glaucoma Filtration Device is intended to reduce intraocular pressure in glaucoma patients where medical and conventional surgical treatments have failed. Clinical study information: A clinical study was performed with the EX-PRESS Glaucoma Filtra- tion Device versions R-30 and R-50. The study was a prospective, open-label multicenter study of 113 open angle glaucoma patients with a follow-up period of one year. Results indicated an 80.4% overall success for the per-protocol cohort (R-30 and R-50, n=58) at one year, where overall success was defined as an IOP reduction greater than 20% from baseline with or without medications. Results indicated a 75.9% overall success for the per-protocol cohort (R-30 and R- 50, n=58) at one year, where overall success was defined as an IOP of less than 21 mm Hg with or without medications. The mean IOP reduction at one year was 33.8%. The percentage reduc- tion from baseline was greater than 28% for the R-30 version and greater than 40% for the R-50 version. The overall average number of glaucoma medications dropped significantly from 1.55 preopera- tive to 0.52 medications at one-year postoperative. The clinical study was not designed to compare between the various versions of the EX-PRESS Glaucoma Filtration Device. The selection of the appropriate version is according to the doctor's discretion. The most commonly reported adverse events included the need for further filtering surgery, device explantation, bleb revision and iris touch. Reasons for device explantation included flat anterior chamber with hypotony, device exposure from erosion, and poor efficacy. Other adverse events such as, but not limited to, corneal and retinal complications, uveitis, and significant reduction in visual acuity, may occur as well. Contraindications: The use of this device is contraindicated if one or more of the following con- ditions exist: Presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis; pre-existing ocular or systemic pathology that, in the opinion of the surgeon, is likely to cause postoperative complications following implantation of the device or patients diagnosed with angle closure glaucoma. Warnings/precautions: The surgeon should be familiar with the instructions for use. The integrity of the package should be examined prior to use and the device should not be used if the package is damaged and sterility is compromised. This device is for single use only. MRI of the head is permitted, however not recommended, in the first two weeks post implantation. Attention: Reference the Directions for Use labeling for a complete listing of indications, warnings, and precautions. INFINITI Vision System Caution: Federal law restricts this device to sale by, or on the order of, a physician. As part of a properly maintained surgical environment, it is recommended that a backup IOL Injector be made available in the event the AutoSert IOL Injector Handpiece does not perform as expected. Indication: The INFINITI Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intraocular lens injec- tion. The INTREPID AutoSert IOL Injector Handpiece is intended to deliver qualified AcrySof intraocular lenses into the eye following cataract removal. The following system modalities additionally support the described indications: –Ultrasound with UltraChopper Tip achieves the functionality of cataract separation. –AquaLase Liquefracture Device achieves the functionality for removal of residual cortical material and lens epithelial cells. –The INTREPID AutoSert IOL Injector Handpiece achieves the functionality of injection of intraocu- lar lenses. The INTREPID AutoSert IOL Injector Handpiece is indicated for use with AcrySof lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof lenses that are specifi- cally indicated for use with this inserter, as indicated in the approved labeling of those lenses. Warnings: Appropriate use of INFINITI Vision System parameters and accessories is important for successful procedures. Use of low vacuum limits, low flow rates, low bottle heights, high power settings, extended power usage, power usage during occlusion conditions (beeping tones), failure to sufficiently aspirate viscoelastic prior to using power, excessively tight incisions, and combina- tions of the above actions may result in significant temperature increases at incision site and inside the eye, and lead to severe thermal eye tissue damage. Adjusting aspiration rates or vacuum limits above the preset values, or lowering the IV pole below the preset values, may cause chamber shallowing or collapse, which may result in patient injury. When filling handpiece test chamber, if stream of fluid is weak or absent, good fluidics response will be jeopardized. Good clinical practice dictates the testing for adequate irrigation and aspira- tion flow prior to entering the eye. Ensure that tubings are not occluded or pinched during any phase of operation. The consumables used in conjunction with ALCON instrument products constitute a complete surgical system. Use of consumables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards. AEs/complications: Use of the NeoSoniX, OZil torsional, U/S, or AquaLase handpieces in the absence of irrigation flow and/or in the presence of reduced or lost aspiration flow can cause excessive heating and potential thermal injury to adjacent eye tissues. Attention: Refer to the directions for use for a complete listing of indications, warnings and precautions. Monarch II/III IOL Delivery System Caution: Federal (U.S.) law restricts this device to the sale by or on the order of a physician. Indications: MONARCH II and III are titanium handpieces that are indicated for use with corre- sponding MONARCH cartridges for the surgical implantation of Alcon foldable intraocular lenses (IOLs). AcrySof IOLs are qualified for use with specific MONARCH handpiece/cartridge combina- tions. No unqualified lenses should be used with the MONARCH II or III IOL Delivery Systems. The MONARCH II and III cartridges are single-use devices. The MONARCH II and III handpieces may be reused after sterilization. Cautions: • Consult the cartridge product information for the correct MONARCH handpiece/cartridge combination to use with a specific AcrySof lens model. • Only use an Alcon qualified viscoelastic for use with the Monarch cartridges. • The MONARCH II and III handpieces are non-sterile and must be thoroughly cleaned and sterilized prior to each use. • Improper cleaning and rinsing of the handpieces has been linked to Toxic Anterior Segment Syndrome. • Potential risks from reuse or reprocessing the MONARCH cartridges include a damaged cartridge, a damaged lens, or an unexpected delivery outcome. • If in the medical opinion of the physician a patient with a prion related disease undergoes a high risk procedure, the instrument should be destroyed or be processed according to local requirements. Attention: Reference the Directions for Use labeling for a complete listing of indications and precautions. The WaveLight FS200 Laser System Federal (U.S.) 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 lamel- lar 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 supervision 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; 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 corneal thickness requirements that are beyond the range of the System.

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