Eyeworld Supplements

ASCRS Copyright 2019 ASCRS Ophthalmic Corporation. All right reserved. The views expressed in this publication do not necessarily reflect those of the staff and leadership of EyeWorld and ASCRS, and in no way imply endorsement by EyeWorld and ASCRS. important product information 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 en- vironment, 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 CENTURION Vision system is indicated for emulsification, separation, irrigation, and aspiration of cataracts, resid- ual 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 cataract removal. The AutoSert IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert IOL Injector Handpiece 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 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 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 conjunction with Alcon instrument products constitute a complete surgical system. Use of consum- ables and handpieces other than those manufactured 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 instrument. Another poten- tial 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 for the accessories/consumables and Operator's Manual for a complete listing of indications, warnings, cautions and notes. LuxOR Microscope As with all ophthalmic microscopes, expo- sure during aphakia should be limited to reduce the risk of damage. During aphakia, limit exposure to red reflex light to no more than 7 minutes. NGENUITY 3D Visualization System Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician. Indication: The NGENUITY 3D Visualiza- tion System consists of a 3D stereoscopic, high-definition digital video camera and workstation to provide magnified stereo- scopic images of objects during micro-sur- gery. It acts as an adjunct to the surgical mi- croscope during surgery displaying real-time images or images from recordings. Warnings: The system is not suitable for use in the presence of flammable anesthet- ics mixture with air or oxygen. There are no known contraindications for use of this device. Precautions: Do not touch any system component and the patient at the same time during a procedure to prevent electric shock. When operating in 3D, to ensure optimal image quality, use only approved passive-polarized glasses. Use of polarized prescription glasses will cause the 3D effect to be distorted. In case of emergency, keep the microscope oculars and mounting accessories in the cart top drawer. If there are any concerns regarding the continued safe use of the NGENUITY 3D Visualization System, consider returning to using the microscope oculars. Attention: Refer to the User Manual for a complete list of appropriate uses, warnings and precautions. ORA SYSTEM Technology Caution: Federal (USA) law restricts this device to the sale by or on the order of a physician. Indications: Federal (USA) law restricts this device to the sale by or on the order of a physician. Intended use: The ORA SYSTEM technol- ogy utilizes wavefront aberrometry data to measure and analyze the refractive power of the eye (i.e., sphere, cylinder, and axis measurements) to support cataract surgical procedures. Warnings and precautions: The following conditions may make it difficult to obtain accurate readings using the ORA SYSTEM technology: • Patients having progressive retinal pathol- ogy such as diabetic retinopathy, macular degeneration, or any other pathology that the physician deems would interfere with patient fixation; • Patients having corneal pathology such as Fuchs,' EBMD, keratoconus, advanced pterygium impairing the cornea, or any other pathology that the physician deems would interfere with the measurement process; • Patients for which the preoperative regi- men includes residual viscous substanc- es left on the corneal surface such as lidocaine gel or viscoelastics; • Visually significant media opacity, such as prominent floaters or asteroid hyalosis, will either limit or prohibit the measure- ment process; or • Patients having received retro or peribulbar block or any other treatment that impairs their ability to visualize the fixation light. • Use of iris hooks during an ORA SYSTEM technology image capture will yield inac- curate measurements. In addition: • Significant central corneal irregularities resulting in higher order aberrations might yield inaccurate refractive measurements. • Post refractive keratectomy eyes might yield inaccurate refractive measurement. • The safety and effectiveness of using the data from the ORA SYSTEM have not been established for determining treatments in- volving higher order aberrations of the eye such as coma and spherical aberrations. • ORA SYSTEM technology is intended for use by qualified health personnel only. • Improper use of this device may result in exposure to dangerous voltage or hazardous laser-like radiation exposure. DO NOT OPERATE the ORA SYSTEM in the presence of flammable anesthetics or vol- atile solvents such as alcohol or benzene, or in locations that present an explosion hazard. Attention: Refer to the ORA SYSTEM Oper- ator's Manual for a complete description of proper use and maintenance, as well as a complete list of contraindications, warnings and precautions. VERION Image Guided System: VERION Reference Unit and VERION Digital Marker Caution: Federal (USA) 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 ref- erence image of a patient's eye. In addition, the VERION Reference Unit provides preop- erative 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 concurrent- ly 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 refer- ence 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 fixa- tion 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 mea- surement 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 Marker for a complete description of proper use and maintenance of these devic- es, as well as a complete list of contraindi- cations, warnings and precautions. © 2019 Alcon 4/19 US-CNT-19-E-0764

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