enVista® IOL EE (REF EEU1950)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10757770607867), received between Apr 23, 2025 and Apr 23, 2025 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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) INTO THE RIGHT EYE, THE PATIENT PRESENTED WITH DECREASED VISUAL ACUITY, A DEEP ANTERIOR CHAMBER, 4+ CELL, FIBRIN AND A 1MM HYPOPYON. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). PATIENT WAS TREATED WITH ORAL PRED 50 MG DAILY FOR 3 DAYS AND PREDNISOLONE. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT WAS THE IMPLANTED IOL. PATIENT OUTCOME WAS REPORTED TO BE GOOD.

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

  MAUDE report 21896672 ↗
• 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 LEFT EYE, THE PATIENT PRESENTED WITH 2+ FIBRIN, HYPOPYON AND 3+ C/F. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). PATIENT WAS TREATED WITH VITREAL VANCOMYCIN AND VITREAL CEFTAZIDIME. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS ENDOPHTHALMITIS, HOWEVER VISION IMPROVED WITH SWIFT INTERVENTION. PATIENT OUTCOME IS GOOD 20/40 AND IMPROVING.

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

  MAUDE report 21895279 ↗