enVista® IOL EE (REF EEU2200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10757770607911), received between Apr 23, 2025 and Jun 18, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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

• InjuryJun 18, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT 11 DAYS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD), THE PATIENT PRESENTED WITH CLINICAL FINDINGS CONSISTENT WITH ENDOPHTHALMITIS. AT THAT TIME, VISUAL ACUITY HAD DECREASED FROM 20/200 TO HAND MOTION. THE PATIENT WAS REFERRED THE SAME DAY TO A RETINA SPECIALIST, WHO DOCUMENTED 1-2 ANTERIOR CHAMBER CELLS, <1MM HYPOPYON, FIBRINOID MEMBRANE AT PUPIL, POSTERIOR SYNECHIAE, AND DENSE VITREOUS OPACITIES. A VITREOUS TAP WAS PERFORMED, AND INTRAVITREAL VANCOMYCIN AND CEFTAZIDIME WAS ADMINISTERED. THE CULTURE SHOWED NO GROWTH. IN THE IMPLANTING SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: PREDNISOLONE 1%: 1 GTT QID X 2 WEEKS, THEN BID X 2 WEEKS (TOTAL DURATION: 1 MONTH) OFLOXACIN 0.3%: 1 GTT QID X 7 DAYS KETOROLAC 0.5%: 1 GTT QID X 2 WEEKS, THEN BID X 2 WEEKS (TOTAL DURATION: 1 MONTH) MEDICATIONS DOCUMENTED AT RETINA VISIT ON (B)(6) 2026: PREDNISOLONE ACETATE: 1% 1 GTT KETOROLAC 0.5%: 1 GTT TID OFLOXACIN 0.3%: 1 GTT QID CYCLOPENTOLATE 1%: 1 GTT TID.

  Patient problems: Endophthalmitis; Hypopyon; Visual Impairment; Vitreous Floaters

  MAUDE report 25551740 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED ABOUT THREE MONTHS AFTER IMPLANTATION DUE TO THE PATIENT EXPERIENCING DYSPHOTOPSIA. A SECOND IOL OF A DIFFERENT MODEL WAS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: Visual Disturbances

  MAUDE report 25253552 ↗
• InjuryApr 23, 2025Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information; Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT ONE DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED FIBRIN AND HYPOPYON WHICH LED THE PATIENT TO BE DIAGNOSED WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT WAS REFERRED TO A RETINA SPECIALIST. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT RECEIVED.

  Patient problems: Hypopyon; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 21894420 ↗