enVista® IOL EE (REF EEU1450)Recalls & reported problems
Bausch & Lomb Incorporated · enVista hydrophobic acrylic IOL (non-preloaded) +14.50D · Class 3 · Implant
All models of enVista IOL (74)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
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 10757770607768), received between Apr 24, 2025 and Apr 24, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Inflammation1
- Mydriasis1
- Toxic Anterior Segment Syndrome (TASS)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE PATIENT PRESENTED WITH PROLONGED INFLAMMATION AND ATONIC PUPIL. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). PATIENT REQUIRED A DESCEMET MEMBRANE ENDOTHELIAL KERATOPLASTY (DMEK) AND PUPILOPLASTY SURGERY. PATIENT OUTCOME WAS REPORTED TO BE GOOD, WITH THEIR VISION BEING 20/20 AFTER THE POSTOP OF THEIR SECOND PROCEDURE.
Patient problems: Inflammation; Mydriasis; Toxic Anterior Segment Syndrome (TASS)
MAUDE report 21898918 ↗
Other intraocular lens devices
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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