AcrySof IQ Vivity Extended Vision IOL implanted in both eyes during cataract surgery

UV-absorbing, with or without blue light filtering, foldable IOL implanted in the capsular bag of the eye for the visual correction of aphakia in adult patients from whom a cataractous lens has been removed. The IOL mitigates the effects of presbyopia by providing an extended depth of focus. The toric models in addition reduce residual refractive astigmatism in patients with pre-existing corneal astigmatism.

Visual acuity (VA) will be assessed binocularly (both eyes together) with correction in place using letter charts at a distance of 4 meters. BCVA will be recorded in logarithm Minimum Angle of Resolution (logMAR) LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity. No hypothesis testing is prespecified for this endpoint.

An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the study device. Adverse events reported or observed since the time of initial exposure to the study model IOL will be recorded.

A device deficiency is defined as an inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance. Device deficiencies reported or observed since the time of initial exposure to the study model IOL will be recorded.