enVista® IOL EE (REF EEU1850)Recalls & reported problems
Bausch & Lomb Incorporated · enVista hydrophobic acrylic IOL (non-preloaded) +18.50D · Class 3 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10757770607843), received between Jun 18, 2026 and Jun 18, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Crack” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Mar 27, 2025Open, Classified
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.
Z-1679-2025 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Crack1
Patient problems
- Corneal Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 18, 2026Crack
IT WAS REPORTED THAT UPON IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE EYE, THE SURGEON OBSERVED A CRACK AT THE OPTIC-HAPTIC JUNCTION. THE INCISION WAS ENLARGED, THE DAMAGED IOL WAS REMOVED, AND A REPLACEMENT LENS WAS IMPLANTED. ACCORDING TO THE SURGEON, THE PATIENT EXPERIENCED SIGNIFICANT POSTOPERATIVE CORNEAL EDEMA, WHICH WAS ATTRIBUTED TO THE EXTENDED SURGICAL TIME AND ADDITIONAL TISSUE MANIPULATION REQUIRED FOR LENS REMOVAL AND REPLACEMENT. IN THE SURGEON'S OPINION, THE MOST LIKE CAUSE OF THE EVENT WAS THE LENS ITSELF, NOTING THAT THE TECHNICIAN DID NOT NOTICE ANY ISSUES DURING LENS LOADING. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: Corneal Edema
MAUDE report 25553427 ↗
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.