Eric D. Donnenfeld, MD
(Moderator)
Professor of Ophthalmology, New York University
Lisa K. Feulner, MD., Ph.D.
Chief Medical Officer and founder of Advanced Eye Care & Aesthetics
I. Paul Singh, MD
President of The Eye Centers of Racine & Kenosha
Dee G. Stephenson, MD, FACS
CEO and Founder of Stephenson Eye Associates
Join Eric Donnenfeld, MD, and panelists Lisa Feulner, MD; I. Paul Singh, MD; and Dee G. Stephenson, MD, FACS, for a discussion on enVista® Envy™ Full Range of Vision IOLs. This live broadcast will review clinical and post-approval data and share real-world insights on patient selection, counseling, and outcomes—including tolerance to visual disturbances and performance across lighting conditions.
enVista Envy toric and non-toric IOL Indications and Important Safety Information
Indications
The enVista Envy hydrophobic acrylic IOL is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia with less than or equal to 1.0 D preoperative corneal astigmatism following removal of a cataractous lens to mitigate the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity to an aspheric monofocal IOL.
The enVista Envy toric hydrophobic acrylic IOL is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens to mitigate the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity to an aspheric monofocal IOL.
Warnings/Precautions
Physicians should weigh the potential risk/benefit ratio before implanting the enVista Envy lens under any of the circumstances or conditions outlined in the Instructions for Use labeling. Some visual disturbances may be expected due to the superposition of focused and unfocused multiple images. These may include some perceptions of halos or radial lines around point sources of light (starbursts) under nighttime conditions, glare, double vision, haziness and blurred vision. It is expected that, in a small percentage of patients, the observation of such phenomena will be annoying and may be perceived as a hindrance, particularly in low illumination conditions such as nighttime driving. As with other trifocal IOLs, there is a possibility that visual disturbances may be significant enough that the patient will request explant of the IOL. A reduction in contrast sensitivity as compared to a monofocal IOL may be experienced by some patients, therefore, patients implanted with trifocal IOLs should exercise caution when driving at night or in low light or poor visibility conditions. Care should be taken to achieve IOL centration as IOL decentration may result in patients experiencing visual disturbances or suboptimal vision under certain lighting conditions. The surgeon must target emmetropia to achieve optimal visual performance. 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). Please provide a copy of the Patient Information Brochure, which can be found at www.bausch.com/IFU. Posterior capsule opacification (PCO) may significantly affect the vision of patients with multifocal IOLs earlier in its progression than patients with monofocal IOLs. This may be due to the reduced contrast sensitivity observed with multifocal IOLs.
Additional Precautions for Toric IOLs: The enVista Envy Toric IOL has not been evaluated in a clinical study. In general, astigmatism that is corrected with a higher cylinder power IOL can result in clinically significant residual astigmatism. The effect of residual astigmatism at distance, intermediate, and near was evaluated in a clinical study of patients who had been implanted with non-toric enVista Envy IOLs and were induced with cylinder power to simulate various levels of residual astigmatism. If a secondary surgical intervention is necessary to reposition the IOL, explantation should be considered as some patients may have recurrent or persistent issues related to rotational instability and misalignment.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
ATTENTION: See the Directions for Use for a complete listing of indications and important safety information.
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