enVista® IOL EE (REF EEU2100)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10757770607898), received between Apr 18, 2025 and Apr 23, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Mar 27, 2025Class IOpen, 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.

• 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, THE PATIENT PRESENTED WITH DECREASED VISUAL ACUITY, INCREASED IOP (PRE-OP 14 MMHG AND POST OP 22 MMHG), HYPOPYON AND POSSIBLE ENDOPHTHALMITIS. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). CULTURES WERE TAKEN AND THE RESULTS WERE NEGATIVE. THE PATIENT WAS TREATED WITH INTRAOCULAR INJECTIONS OF CEFTAZIDINE AND VANCOMYCIN, SUB TENONS KENALOG, DUREZOL AND OFLOXACIN. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT WAS RELATED TO THE IMPLANTED IOL. PATIENT OUTCOME WAS REPORTED TO BE GOOD.

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

  MAUDE report 21896675 ↗
• 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 POOR VISION WITH NO PAIN. SLIT LAMP FINDINGS WERE 1+ EDEMA, 4+ CELL WITH FIBRIN, 1+ SPK NUCLEAR FRAGMENT. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE FRAGMENT WAS REMOVED AND THE PATIENT'S OUTCOME IS GOOD. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT TASS. THE FOLLOWING MEDICATIONS WERE PRESCRIBED (FOR USE AT HOME POST-OPERATIVELY): PRED/MOXI/NEPA, PRED ACETATE AND MEDROL DOSE PACK.

  Patient problems: Corneal Edema; Keratitis; Toxic Anterior Segment Syndrome (TASS); Visual Impairment

  MAUDE report 21896030 ↗
• InjuryApr 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED. THE PATIENT'S BEST CORRECTED VISION FOR FINAL OUTCOME WAS 20/20 IN THE AFFECTED EYE.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 21865609 ↗