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.
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. Distribution: Worldwide distribution. US Nationwide including PR and GU, and the countries of CAN, AUS, AUT, BEL, BGR, IC, HRV, CZE, FRA, DEU, GRC, HUN, ITA, NLD, POL, PRT, ROU, ESP, GBR, NZL, HKG. Quantity: 48,237 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, 3Q25119, 3Q25421, 3Q25422, 3Q25423, 3Q25424, 3Q25506, 3Q25834, 3Q25922, 3Q25923, 3Q26525, 3Q26527, 3Q26539, 3Q26602, 3Q26605, 3Q27252, 3Q27321, 3Q27322, 3Q27323, 3Q27324, 3Q27354, 3Q27456, 3Q27458, 3Q27906, 3Q27908, 3Q28003, 3Q28004, 3Q28011, 3Q28012, 3Q28802, 3Q29017, 3Q29018, 3Q29022, 3Q29203, 3Q29204, 3Q29303, 3Q29402, 3Q29404, 3Q29546, 3Q29550, 3Q29635, 3Q30211, 3Q30213, 3Q32503, 3Q33816, 3Q33817, 3Q33818, 3Q33819, 3Q33820, 3Q33821, 3Q33823, 3Q33920, 3Q33922, 3Q33926, 3Q33927, 3Q33929, 3Q34032, 3Q34033, 3Q3
10757770636478, 10757770637017, 10757770637031, 10757770637055, 10757770637079, 10757770637543, 10757770637093, 10757770637109, 10757770637536, 10757770637116, 10757770637123, 10757770637130, 10757770637147, 10757770637154, 10757770637161, 10757770637178, 10757770637185, 10757770637192, 10757770637208, 10757770637215, 10757770637222, 10757770637239, 10757770637246, 10757770637253, 10757770636485, 10757770637550, 10757770637277, 10757770637284, 10757770637291, 10757770637307, 10757770637314, 10757770637321, 10757770637338, 10757770637345, 10757770637352, 10757770637369, 10757770637376, 10757770637383, 10757770637390, 10757770637406
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.