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: 236,840 Lot/code info: Description/Lots/UDI-DI: enVista Monofocal IOL (EEU)/3Q25120, 3Q25326, 3Q25327, 3Q25347, 3Q25348, 3Q25425, 3Q25426, 3Q25427, 3Q25507, 3Q25508, 3Q25509, 3Q25510, 3Q25511, 3Q25548, 3Q25549, 3Q25550, 3Q25628, 3Q25632, 3Q25730, 3Q25731, 3Q25840, 3Q25843, 3Q25934, 3Q25935, 3Q25936, 3Q25937, 3Q25938, 3Q25939, 3Q25940, 3Q25941, 3Q25942, 3Q25943, 3Q25944, 3Q26009, 3Q26010, 3Q26041, 3Q26042, 3Q26043, 3Q26044, 3Q26069, 3Q26070, 3Q26071, 3Q26072, 3Q26119, 3Q26120, 3Q26121, 3Q26122, 3Q26123, 3Q26202, 3Q26203, 3Q26204, 3Q26220, 3Q26255, 3Q26262, 3Q26301, 3Q26305, 3Q26306, 3Q26328, 3Q26329, 3Q26330, 3Q26331, 3Q26332, 3Q26333, 3Q26334, 3Q26348, 3Q26422, 3Q26424, 3Q26425, 3Q26444, 3Q26445, 3Q26446, 3Q26520, 3Q26521, 3Q26522, 3Q26614, 3Q26617, 3Q26618, 3Q26681, 3Q26682, 3Q26683, 3Q26684, 3Q26733, 3Q26734, 3Q26735, 3Q26747, 3Q26801, 3Q26802, 3Q26833, 3Q26834, 3Q26835, 3Q26836, 3Q26911, 3Q26912, 3Q26913, 3Q26914, 3Q26916, 3Q27101, 3Q27102, 3Q27103, 3Q27104, 3Q27201, 3Q27202, 3Q27203, 3Q27226, 3Q27253, 3Q27254, 3Q27255, 3Q27336, 3Q27337, 3Q27450, 3Q27451, 3Q27452, 3Q27453, 3Q27454, 3Q27455, 3Q27520, 3Q27620, 3Q27808, 3Q27809, 3Q27928, 3Q27929, 3Q27930, 3Q28021, 3Q28022, 3Q28101, 3Q28137, 3Q28138, 3Q28139, 3Q28712, 3Q28713, 3Q28714, 3Q28812, 3Q28813, 3Q28815, 3Q28816, 3Q28913, 3Q28914, 3Q28915, 3Q29033, 3Q29034, 3Q29140, 3Q29141, 3Q29142, 3Q29215, 3Q29216, 3Q29217, 3Q29218, 3Q29255, 3Q29319, 3Q29320, 3Q29422, 3Q29423, 3Q29424, 3Q29425, 3Q29524, 3Q29526, 3Q29537, 3Q29646, 3Q29647, 3Q29648, 3Q29649
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Official record: FDA (Device enforcement) ↗
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