Recall Z-1679-2025 ยท HQL Intraocular Lens
Bausch & Lomb Surgical, Inc.
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;
| Date | May 2, 2025 (initiated Mar 27, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | On 3/27/2025, a news release was published informing customers that the firm will send out detailed instructions for what to do with any stock on hand. On 4/4/2025, the news release was updated and customers were also informed in a recall notice of the following: For Patients: Cataract surgery patients experiencing eye discomfort should contact their eyecare professional immediately. For Eyecare Professionals: Continue to closely monitor cataract surgery patients for at least 48 hours after surgery. Please instruct patients with new or worsening symptoms to contact your office immediately. |
| Quantity | 236,840 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.