enVista® IOL EE (REF EEU2450)Recalls & reported problems
Bausch & Lomb Incorporated · enVista hydrophobic acrylic IOL (non-preloaded) +24.50D · Class 3 · Implant
Data updated Oct 13, 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 10757770607966), received between Apr 18, 2025 and Apr 18, 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
- Toxic Anterior Segment Syndrome (TASS)1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT NINE DAYS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE PATIENT PRESENTED WITH DEPOSITS ON ANTERIOR LENS SURFACE WITH DECLINE IN VISION AS COMPARED TO IMMEDIATE POST OP VISION. SLIT LAMP FINDINGS WERE WHITE MATERIAL ON LENS SURFACE WITH 3+ FLARE. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). CULTURE RESULTS WERE NEGATIVE. TREATMENT INCLUDED INTRAVITREAL INJECTIONS OF VANCOMYCIN, CEFTAZIDIME AND DEXAMETHASONE. PATIENT OUTCOME IS GOOD, HOWEVER INTERVENTION IS ONGOING WITH RETINA SPECIALIST. THE FOLLOWING MEDICATIONS WERE PRESCRIBED (FOR USE AT HOME POST-OPERATIVELY): LEVOFLOXACIN.
Patient problems: Toxic Anterior Segment Syndrome (TASS); Visual Impairment
MAUDE report 21865039 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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