enVista® IOL EE (REF EEU2250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10757770607928), 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.

Recalls naming this device

1. 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

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 1 DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE PATIENT PRESENT WITH BLURRY VISION WITH BEST CORRECTED DISTANCE VISUAL ACUITY DECREASING TO 20/150 PH, THUMBPRINT FLOATER, 0.2MM HYPOPYON W/TEMPORAL FIBRIN, 3-5 + WHITE CELLS, AND ROBUST INFLAMMATORY RESPONSE CONTINUING INTO THE NEXT DAY. ON DAY 3 POST-OP, THE PATIENT COMPLAINED OF LIGHT SENSITIVITY, SEEING A CHECKERED PATTERN, AND WHITE BLOBS WITH BLACK WORMS EVERYWHERE WITH VISUAL ACUITY FURTHER DECREASING. UPON EXAMINATION, THE SURGEON NOTED INCREASED VITREOUS OPACITIES AND RETINAL HEMORRHAGES AND WAS REFERRED FOR A VITREOUS TAP & INJECTIONS OF 1MG VANCOMYCIN, 100MG CEFTAZIDIME, & 0.4MG DEXAMETHASONE WERE ADMINISTERED. RESULTS OF THE CULTURE & SENSITIVITY WERE NEGATIVE. PATIENT OUTCOME IS GOOD. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: MOXIFLOXACIN GTT 0.5% 3X 1 DAY (INCREASED TO AID) TAPER. PREDNISOLONE GTT 1% 3X 1 DAY (INCREASED Q HOUR) TAPER. PROLENSA GTT 0.07% 1 X DAY (INCREASED QID) TAPER. MEDROL PACK 4 MG TAB TAKE AS DIRECTED ON PACK. DUREZOL 0.05% 1 GTT Q HR.

  Patient problems: Hypopyon; Intraocular Pressure Increased; Photophobia; Retinal Hemorrhage; Toxic Anterior Segment Syndrome (TASS); Visual Impairment; Vitreous Floaters

  MAUDE report 21893664 ↗