12/30/2023 0 Comments Xwave playground equipment![]() In the parent 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. It is possible to experience very bothersome visual disturbances, significant enough that the patient could request explant of the 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 environments, such as driving at night or in poor visibility conditions, especially in the presence of oncoming traffic. Therefore, it is essential that prospective patients be fully informed of this risk before giving their consent for implantation of the Clareon ® Vivity ® IOL. Most patients implanted with the Clareon ® Vivity ® IOL are likely to experience significant loss of contrast sensitivity as compared to a monofocal IOL. Rotation can reduce astigmatic correction if necessary, lens repositioning should occur as early as possible prior to lens encapsulation. This lens should not be implanted if the posterior capsule is ruptured, if the zonules are damaged, or if a primary posterior capsulotomy is planned. 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. In addition, the Clareon ® Vivity ® Toric IOL is indicated for the reduction of residual refractive astigmatism in adult patients with pre-existing corneal astigmatism. ![]() ![]() The Clareon ® Vivity ® IOL is intended for capsular bag placement only. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The lens mitigates the effects of presbyopia by providing an extended depth of focus. INDICATIONS: The Clareon ® Vivity ® Extended Vision Hydrophobic Posterior Chamber IOLs include Clareon ® Vivity ® and Clareon ® Vivity ® Toric IOLs and are indicated for primary implantation for the visual correction of aphakia in adult patients with <1.00 D of preoperative corneal astigmatism, in whom a cataractous lens has been removed by extracapsular cataract extraction. IMPORTANT PRODUCT INFORMATION: CLAREON ® VIVITY ® FAMILY OF EXTENDED VISION IOLSĬAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. ¶ Response to the following question in IOLSAT questionnaire at 6 months post-op: “Given your vision today, if you had to do it all over, would you have the same lens implanted again?” AcrySof ® IQ Vivity ® and Clareon ® Vivity ® are optically equivalent. A Snellen notation of 20/20-2 or better indicates a logMAR VA of 0.04 or better, which means 3 or more of the 5 ETDRS chart letters in the line were identified correctly. ‡ Snellen VA was converted from logMAR VA. † Results from a prospective, randomized, parallel group, subject- and assessor-masked, multisite trial of 107 subjects bilaterally implanted with the AcrySof ® IQ Vivity ® IOL and 113 with the AcrySof ® IQ IOL with 6 months follow-up. * Based on in vitro examinations of glistenings, surface haze and SSNGs.
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