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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: Cataract Surgery 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, phacofragmentation, 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. Corneal Flap Indication The LenSx ® Laser is indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea. 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: Cataract Surgery 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, glaucoma* 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. *Glaucoma is not a contraindication when these procedures are performed using the LenSx ® Laser SoftFit™ Patient Interface Accessory Corneal Flap Contraindications • Corneal lesions • Corneal edema • Hypotony • Glaucoma • Existing corneal implant • Keratoconus • 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 Patient Interface consisting of an applanation lens and suction ring. The Patient Interface is intended for single use only. The dispos- ables 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 literature, 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. Complications: Cataract Surgery 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 Corneal Flap AEs/Complications • Corneal edema • Corneal pain • Epithelial in-growth • Epithelial defect • Infection • Flap decentration • Incomplete flap creation • Flap tearing or incomplete lift-off • Free cap Attention: Refer to the LenSx ® Laser Operator's Manual for a complete listing of indications, warnings and precautions. Caution: Federal (U.S.) law restricts this device to sale by, or on the order of, a physician. Intended Uses: The VERION ™ Reference Unit is a preoperative measurement device that captures and utilizes a high-resolution reference image of a patient's eye. In addition, the VERION ™ Reference Unit provides preoperative surgical planning functions to assist the surgeon with planning cataract surgical procedures. The VERION ™ Reference Unit also supports the export of the reference image, preoperative measurement data, and surgical plans for use with the VERION ™ Digital Marker and other compatible devices through the use of a USB memory stick. The VERION ™ Digital Marker links to compatible surgical microscopes to display concurrently the reference and microscope images, allowing the surgeon to account for lateral and rotational eye movements. In addition, details from the VERION ™ Reference Unit surgical plan can be overlaid on a computer screen or the physician's microscope view. Contraindications: The following conditions may affect the accuracy of surgical plans prepared with the VERION™ Reference Unit: a pseudophakic eye, eye fixation problems, a non-intact cornea, or an irregular cornea. In addition, patients should refrain from wearing contact lenses during the reference measurement as this may interfere with the accuracy of the measurements. The following conditions may affect the proper functioning of the VERION ™ Digital Marker: changes in a patient's eye between preoperative measurement and surgery, an irregular elliptic limbus (e.g., due to eye fixation during surgery, and bleeding or bloated conjunctiva due to anesthesia). In addition, the use of eye drops that constrict sclera vessels before or during surgery should be avoided. Warnings: Only properly trained personnel should operate the VERION ™ Reference Unit and VERION ™ Digital Marker. Use only the provided medical power supplies and data communication cable. Power supplies for the VERION™ Reference Unit and the VERION ™ Digital Marker must be uninterruptible. Do not use these devices in combination with an extension cord. Do not cover any of the component devices while turned on. The VERION™ Reference Unit uses infrared light. Unless necessary, medical personnel and patients should avoid direct eye exposure to the emitted or reflected beam. Precautions: To ensure the accuracy of VERION ™ Reference Unit measurements, device calibration and the reference measurement should be conducted in dimmed ambient light conditions. Only use the VERION ™ Digital Marker in conjunction with compatible surgical microscopes. Attention: Refer to the user manuals for the VERION™ Reference Unit and the VERION ™ Digital Mark- er for a complete description of proper use and maintenance of these devices, as well as a complete list of contraindications, warnings and precautions. VERION ™ Image Guided System This supplement was produced by EyeWorld and sponsored by Alcon Laboratories Inc. LenSx is a trademark of Alcon Laboratories Inc. or its affiliates. Copyright 2015 ASCRS Ophthalmic Corporation. All rights reserved. The views expressed here do not necessarily reflect those of the editor, editorial board, publisher, or the sponsor and in no way imply endorsement by EyeWorld or ASCRS. VERION ™ Reference Unit and VERION™ Digital Marker Product information 10/15 US-LSX-15-E-0613

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