Eyeworld Supplements

Going beyond: Unique technologies designed to help your patients see brilliantly Copyright 2023 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. © 2023 Alcon Inc. 5/23 US-CLI-2300100 Important Product Information Clareon® Family of IOLs CAUTION: Federal law restricts these devices to sale by or on the order of a physician. INDICATION: The family of Clareon® intraocular lenses (IOLs) includes the Clareon® Aspheric Hydrophobic Acrylic and Clareon® Aspheric Toric IOLs, the Clareon® PanOptix® Trifocal Hydrophobic IOL, Clareon® PanOptix® Toric, Clareon® Vivity™ Extended Vision Hydrophobic Posterior Chamber IOL and Clareon® Vivity™ Toric IOLs. Each of these IOLs is indicated for visual correction of aphakia in adult patients following cataract surgery. In addition, the Clareon® Toric IOLs are indicated to correct pre-existing corneal astigmatism at the time of cataract surgery. The Clareon® PanOptix® lens mitigates the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining com- parable distance visual acuity with a reduced need for eyeglasses, compared to a monofocal IOL. The Clareon® 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 General cautions for all Clareon® IOLs: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/ benefit ratio before implanting any IOL in a patient with any of the conditions described in the Directions for Use that accompany each IOL. Physicians should target emmetropia and ensure that IOL centration is achieved. For the Clareon® Aspheric Toric, PanOptix® Toric and Vivity™ Toric 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 possi- ble prior to lens encapsulation. For the Clareon® 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 progression than patients with monofocal IOLs. For the Clareon® Vivity™ IOL, most patients implanted with the Vivity™ IOL are like- ly to experience significant loss of contrast sensitivity as compared to a monofocal IOL. Therefore, it is essential that prospective patients be fully informed of this risk before giving their consent for implantation of the Clareon® Vivity™ IOL. In addi- tion, patients should be warned that they will need to exercise caution when engag- ing in activities that require good vision in dimly lit environments, such as driving at night or in poor visibility conditions, especially in the presence of oncoming traffic. It is possible to experience very bothersome visual disturbances, significant enough that the patient could request explant of the IOL. In the parent AcrySof® IQ Vivity™ IOL clinical study, 1% to 2% of AcrySof® IQ Vivity™ IOL patients reported very bother- some 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 Brochure 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. Hydrus Microstent CAUTION: Federal law restricts this device to sale by or on the order of a physician. INDICATIONS FOR USE: The Hydrus Microstent is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult pa- tients with mild to moderate primary open-angle glaucoma (POAG). CONTRAINDICATIONS: The Hydrus Microstent is contraindicated under the follow- ing circumstances or conditions: (1) In eyes with angle closure glaucoma; and (2) In eyes with traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber (AC) angle. WARNINGS: Clear media for adequate visualization is required. Conditions such as corneal haze, corneal opacity, or other conditions may inhibit gonioscopic view of the intended implant location. Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, peripheral anterior synechiae (PAS), angle closure, rubeosis and any other angle abnormalities that could lead to improper placement of the stent and pose a hazard. The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. The surgeon should periodically monitor the status of the microstent with gonioscopy to assess for the development of PAS, obstruction of the inlet, migration, or device-iris or device-cornea touch. The Hydrus Microstent is intended for implantation in conjunction with cataract surgery, which may impact corneal health. Therefore, caution is indicated in eyes with evidence of corneal compromise or with risk factors for corneal compromise following cataract surgery. Prior to implantation, patients with history of allergic reactions to nitinol, nickel or titanium should be counseled on the materials contained in the device, as well as potential for allergy/hypersensitivity to these materials. PRECAUTIONS: If excessive resistance is encountered during the insertion of the microstent at any time during the procedure, discontinue use of the device. The safety and effectiveness of use of more than a single Hydrus Microstent has not been established. The safety and effectiveness of the Hydrus Microstent has not been established as an alternative to the primary treatment of glaucoma with med- ications, in patients 21 years or younger, eyes with significant prior trauma, eyes with abnormal anterior segment, eyes with chronic inflammation, eyes with glaucoma associated with vascular disorders, eyes with preexisting pseudophakia, eyes with pseudoexfoliative or pigmentary glaucoma, and when implantation is without concomitant cataract surgery with IOL implantation. Please see a complete list of Precautions in the Instructions for use. ADVERSE EVENTS: The most frequently reported finding in the randomized pivotal trial was peripheral anterior synechiae (PAS), with the cumulative rate at 5 years (14.6% vs 3.7% for cataract surgery alone). Other Hydrus postoperative adverse events reported at 5 years included partial or complete device obstruction (8.4%) and device malposition (1.4%). Additionally, there were no new reports of persistent anterior uveitis (2/369, 0.5% at 2 years) from 2 to 5 years postoperative. There were no reports of explanted Hydrus implants over the 5-year follow-up. For additional adverse event information, please refer to the Instructions for Use. MRI INFORMATION: The Hydrus Microstent is MR-Conditional meaning that the de- vice is safe for use in a specified MR environment under specified conditions. Please see the Instructions for Use for complete product information. 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 stereo- scopic 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 anes- thetics 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 polar- ized prescription glasses will cause the 3D effect to be distorted. In case of emergen- cy, 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.

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