enVista® IOL EE (REF EEU2050)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10757770673930), received between Apr 23, 2025 and Jul 11, 2025 — classified as 3 injuries.

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.

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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE PATIENT COMPLAINED OF SYMPTOMS CONSISTENT WITH NEGATIVE DYSPHOTOPSIA. THE PATIENT DID NOT NOTICE A DECREASE IN VISION. APPROXIMATELY 10 WEEKS AFTER THE ONSET OF SYMPTOMS, THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL IOL. PATIENT OUTCOME IS GOOD.

  Patient problems: Visual Disturbances

  MAUDE report 22479889 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY AFTER ONE MONTH IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL IOL DUE TO ONGOING DYSPHOTOPSIA. THE PATIENT OUTCOME IS GOOD.

  Patient problems: Visual Disturbances

  MAUDE report 21934568 ↗
• 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 LEFT EYE (OS), THE PATIENT PRESENTED WITH SIGNIFICANT INFLAMMATION, INCREASED INTRAOCULAR PRESSURE, 4+ CELL, AND 1+ DEBRIS. THE PATIENT'S BCVA DID NOT DECREASE. THE SURGEON STATED THAT ON EVALUATION IT LOOKED LIKE THERE WAS A RETAINED LENS FRAGMENT, BUT THE APPEARANCE OF A FRAGMENT WAS NOT SEEN 4 DAYS LATER. THE SYMPTOMS IMPROVED WITH PREDNISOLONE. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). PATIENT OUTCOME IS GOOD. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: POLYMYXIN B 1MG/1ML QID COMBIGAN BID X 1 WEEK. PREDNISOLONE 1% 6X DAY X 1 WEEK.

  Patient problems: Intraocular Pressure Increased; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 21894166 ↗