Eyeworld Daily News

CENTURION ® Vision System Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician. As part of a properly maintained surgical environment, it is recom- mended that a backup IOL Injector be made available in the event the AutoSert ® IOL Injector Handpiece does not perform as expected. Indication: The CENTURION ® Vision system is indicated for emul- sification, separation, irrigation, and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intraocular lens injection. The AutoSert ® IOL Injector Handpiece is intended to deliver qualified AcrySof ® intraocular lenses into the eye following cata- ract removal. The AutoSert ® IOL Injector Hand- piece achieves the functionality of injection of intraocular lenses. The AutoSert ® IOL Injector Hand- piece is indicated for use with the AcrySof ® lenses SN6OWF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof ® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses. Warnings: Appropriate use of CENTURION ® Vision System param- eters 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 (beep- ing tones), failure to sufficiently aspirate viscoelastic prior to using power, excessively tight incisions, and combinations 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. Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye. Ensure that tubings are not occluded or pinched during any phase of operation. The consumables used in conjunc- tion with ALCON ® instrument prod- ucts constitute a complete surgical system. Use of consumables and handpieces other than those manu- factured by Alcon may affect system performance and create potential hazards. AEs/complications: Inadvertent actuation of Prime or Tune while a handpiece is in the eye can create a hazardous condition that may result in patient injury. During any ultra- sonic procedure, metal particles may result from inadvertent touching of the ultrasonic tip with a second in- strument. Another potential source of metal particles resulting from any ultrasonic handpiece may be the result of ultrasonic energy causing micro abrasion of the ultrasonic tip. Attention: Refer to the Directions for Use and Operator's Manual for a complete listing of indications, warnings, cautions and notes. LenSx ® Laser United States Federal Law restricts this device to sale and use by or on the order of a physician or licensed eyecare practitioner. Indications Cataract surgery indication The LenSx ® Laser is indicated for use in patients undergoing cat- aract 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. • Patient must be able to under- stand 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 contraindica- tion 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 disposables used in conjunction with ALCON® instrument products constitute a complete surgical system. Use of disposables other than those manu- factured 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. Important product information EW San Diego 2015 7

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