Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.

Summary

The FDA issued a Class I for Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy T by Bausch & Lomb Surgical, Inc.. Reason: In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista.

Details

Product Description

Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.

Lot/Code Info: Description/Lots/UDI-DI: enVista Envy IOL (ENU)/3Q24764, 3Q24935, 3Q25113, 3Q25833, 3Q26256, 3Q26257, 3Q26538, 3Q26601, 3Q26603, 3Q26604, 3Q26679, 3Q26680, 3Q27353, 3Q27447, 3Q27457, 3Q27905, 3Q27907, 3Q28001, 3Q28002, 3Q28124, 3Q28125, 3Q28801, 3Q28901, 3Q28903, 3Q28904, 3Q28905, 3Q28906, 3Q29020, 3Q29021, 3Q29205, 3Q29266, 3Q29301, 3Q29302, 3Q29304, 3Q29305, 3Q29306, 3Q29401, 3Q29403, 3Q29405, 3Q29406, 3Q29545, 3Q29547, 3Q29548, 3Q29636, 3Q29637, 3Q29835, 3Q29837, 3Q30210, 3Q30310, 3Q30311, 3Q33702, 3Q33822, 3Q33918, 3Q33921, 3Q33924, 3Q33925, 3Q33928, 3Q34031, 3Q34034, 3Q34205, 3Q35006, 3Q35733, 3Q35735, 3Q35736, 3Q35738, 3Q35813, 3R01610, 3R01611, 3R02532, 3R02534, 3R02536, 3R02537, 3R02540, 3R02542, 3R02551, 3R02553, 3R02608, 3R02749, 3R02750, 3R02846, 3R03533, 3R03534, 3R03536, 3R03804, 3R03805, 3R03806, 3R04414, 3R04533, 3R05051, 3R05411, 3Q24749, 3Q24750, 3Q24751, 3Q24756, 3Q24763, 3Q24765, 3Q24766, 3Q24837, 3Q24842, 3Q24934, 3Q25115, 3Q25116, 3Q25117, 3Q25118, 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10757770643773, 10757770643780, 10757770643797, 10757770643803, 10757770643810, 10757770643827, 10757770643834, 10757770643841, 10757770643858, 10757770643865, 10757770643872, 10757770643889, 10757770643896, 10757770643902, 10757770643919, 10757770643926, 10757770643933, 10757770643940, 10757770643957, 10757770643964, 10757770643971, 10757770643988, 10757770643995, 10757770644008, 10757770644015, 10757770644022, 10757770644039, 10757770644046, 10757770644053, 10757770644060, 10757770644077, 10757770644084, 10757770644091, 10757770644107, 10757770644114, 10757770644121, 10757770644138, 10757770644145, 10757770644152, 10757770644169, 10757770644176, 10757770644183, 10757770644190, 10757770644206, 10757770644213, 10757770644220, 10757770644237, 10757770644244, 10757770644251, 10757770644268, 10757770644275, 10757770644282, 10757770644299, 10757770644305, 10757770644312, 10757770644329, 10757770644336, 10757770644343, 10757770644350, 10757770644367, 10757770644374, 10757770644381, 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10757770645654, 10757770645661, 10757770645678, 10757770645685, 10757770645692, 10757770645708, 10757770636607

Quantity Affected: 48,237

Reason for Recall

In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-03-27

Company