SEP 2021

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

Issue link: https://digital.eyeworld.org/i/1400530

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Page 106 of 106

STEP FORWARD INTO THE NEXT GENERATION OF CATARACT SURGERY IMPORTANT PRODUCT INFORMATION AcrySof® IQ PanOptix® and Vivity™ Family of IOLs Caution: Federal (USA) law restricts this device to the sale by or on the order of a physician. Indications The AcrySof® IQ PanOptix® Trifocal IOL, AcrySof® IQ PanOptix® Toric, AcrySof® IQ Vivity™ Extended Vision IOL and AcrySof® IQ Vivity™ Toric IOLs are indicated for visual correction of aphakia in adult patients following cataract surgery. In addition, the AcrySof® Toric IOLs are indicated to correct pre-existing corneal astigmatism at the time of cataract surgery. The AcrySof® IQ PanOptix® lens mitigates the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity with a reduced need for eye- glasses, compared to a monofocal IOL. The AcrySof® IQ Vivity™ lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. All of these IOLs are intended for placement in the capsular bag. Warnings/precautions: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Physicians should target emmetropia and ensure that IOL centration is achieved. For the PanOptix® Toric and Vivity™ IOLs, the lens should not be implanted if the posterior capsule is ruptured, if the zonules are damaged, or if a primary posterior capsulotomy is planned. Rotation can reduce astigmatic correction; if necessary lens repositioning should occur as early as possible prior to lens encap- sulation. For the AcrySof® IQ PanOptix® IOL, some visual effects may be expected due to the superposition of focused and unfocused multiple images. These may include some perceptions of halos or starbursts, as well as other visual symptoms. As with other multifocal IOLs, there is a possibility that visual symptoms may be significant enough that the patient will request explant of the multifocal IOL. A reduction in contrast sensitivity as compared to a monofocal IOL may be experienced by some patients and may be more prevalent in low lighting conditions. Therefore, patients implanted with multifocal IOLs should exercise caution when driving at night or in poor visibility conditions. Patients should be advised that unexpected outcomes could lead to continued spectacle dependence or the need for secondary surgical intervention (e.g., intraocular lens replacement or repositioning). As with other multifocal IOLs, patients may need glasses when reading small print or looking at small objects. Posterior capsule opacification (PCO) may significantly affect the vision of patients with multifocal IOLs sooner in its progres- sion than patients with monofocal IOLs. For the AcrySof® IQ Vivity™ IOL, most patients implanted with the Vivity™ IOL are likely to experience significant loss of contrast sensitivity as compared to a monofocal IOL. Therefore, it is essential that pro- spective patients be fully informed of this risk before giving their consent for implantation of the AcrySof® IQ Vivity™ IOL. In addition, patients should be warned that they will need to exercise caution when engaging in activities that require good vision in dimly lit envi- ronments, such as driving at night or in poor visibility conditions, especially in the presence of oncoming traf- fic. It is possible to experience very bothersome visual disturbances, significant enough that the patient could request explant of the IOL. In the AcrySof® IQ Vivity™ IOL clinical study, 1% to 2% of AcrySof® IQ Vivity™ IOL patients reported very bothersome starbursts, halos, blurred vision, or dark area visual disturbances; however, no explants were reported. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Bro- chure available from Alcon informing them of possible risks and benefits associated with these IOLs. Attention: Reference the Directions for Use labeling for each IOL for a complete listing of indications, warnings, and precautions. ARGOS® Optical Biometer Caution: Federal (USA) law restricts this device to the sale by or on the order of a physician. Indications: ARGOS® is a non-invasive, non-contact biometer based on swept-source optical coherence to- mography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. Intended use: The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool. It is intended for use by ophthal- mologists, physicians, and other eyecare professionals and may only be used under the supervision of a physician. Warnings and Precautions: Only properly trained personnel with experience may operate the device and control software and interpret the results. Factors that influence the measurement of patients' eyes are listed in the User Manual (Table 1): pseudophakic eye, wearing contact lenses, fixation problem, cornea opacity, non-intact cornea, refractive surgery, blood in the vitreous humor, retinal detachment, keratoconus, asteroid hyalosis, ambient light in the room, and deformation of the corneal shape. Please consider the guidance provid- ed in Table 1 when you encounter these factors. Optical Radiation – This device is equipped with a Class 1 laser light source. Attention: Refer to the ARGOS® User Manual for a complete description of proper use and maintenance, optical and technical specifications, as well as a com- plete list of warnings and precautions. NGENUITY™ 3D Visualization System for the Digitally Assisted Vitreoretinal Surgery Platform Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician. Indication: The NGENUITY™ 3D Visualization System consists of a 3D stereoscopic, high-definition digital video camera and workstation to provide magnified stereoscopic images of objects during microsurgery. It acts as an adjunct to the surgical microscope during surgery displaying real-time images or images from recordings. Warnings: The system is not suitable for use in the presence of flammable anesthetics 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 prescrip- tion 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. Copyright 2021 ASCRS Ophthalmic Corporation. All rights 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. © 2021 Alcon Inc 7/21 US-ACP-2100116

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