Bausch & Lomb Surgical, Inc. medical device recall: Intraocular lens. enVista Monofocal IOL

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.

What the classification means

• Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Mar 27, 2025. FDA classified it 36 days later, on May 2, 2025. This recall event covers 2 separate products, each with its own FDA recall number. Distribution reported by FDA: 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. Bausch & Lomb Surgical, Inc. has 8 recalls in our records.

Recalled products (2)

• Z-1679-2025 Class I Ongoing

  Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA;

  Codes / lots: 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,…

  Quantity: 236,840

• Z-1680-2025 Class I Ongoing

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

  Codes / lots: 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,…

  Quantity: 48,237