enVista® IOL EE (REF EEU1750)Recalls & reported problems
Bausch & Lomb Incorporated · enVista hydrophobic acrylic IOL (non-preloaded) +17.50D · 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 10757770607829), received between Apr 23, 2025 and Apr 23, 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. 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
- Insufficient Device Problem Information1
Patient problems
- Corneal Edema1
- Hypopyon1
- 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 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT ONE DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE PATIENT PRESENTED WITH CORNEAL EDEMA, HYPOPYON, AND FIBROUS BONDS ACROSS PUPIL. BASED ON THE FINDINGS, THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). A VITREOUS TAP WAS PERFORMED BY RETINA; HOWEVER, CULTURE RESULTS ARE NOT AVAILABLE. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS TASS. PATIENT OUTCOME IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Corneal Edema; Hypopyon; Toxic Anterior Segment Syndrome (TASS)
MAUDE report 21895437 ↗
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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.