FDA Device recall Z-1679-2025
Intraocular lens. enVista Monofocal IOL, All models starting with EE
- FDA Device
- Class I
- ongoing
- Published 2025-05-14
On 2025-05-14 the FDA classified a Class I recall of Intraocular lens. enVista Monofocal IOL, All models starting with EE by Bausch And Lomb Surgical, citing 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 enVis….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1679-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-03-27 |
| Published | 2025-05-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Bausch And Lomb Surgical |
| Distribution | US |
Product
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;
Reason
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.
Identifiers
| code_info | Description/Lots/UDI-DI: enVista Monofocal IOL (EEU)/3Q25120, 3Q25326, 3Q25327, 3Q25347, 3Q25348, 3Q25425, 3Q25426, 3Q2…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, 3Q |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Bausch And Lomb Surgical
- Akreos, SKU: AO60P0300
FDA Device · Class III · 2025-09-03 · Bausch And Lomb Surgical - Intraocular Lens. enVista Envy IOL, All models starting with EN
FDA Device · Class I · 2025-05-14 · Bausch And Lomb Surgical - MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placeme…
FDA Device · Class II · 2020-12-09 · Bausch And Lomb Surgical - enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the…
FDA Device · Class II · 2020-07-22 · Bausch And Lomb Surgical - enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adul…
FDA Device · Class II · 2018-12-26 · Bausch And Lomb Surgical
All Bausch And Lomb Surgical recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1679-2025%22
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