enVista Envy™ Toric IOL ETN (REF ETNU125+230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10757770640338), received between Apr 17, 2025 and Jan 16, 2026 — classified as 5 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-1680-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT FOUR MONTHS POST RIGHT EYE IOL (INTRAOCULAR LENS) IMPLANTATION, THE LENS WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING DYSPHOTOSIA. A NEW LENS OF THE SAME MODEL WAS PLACED AND THE PATIENT IS CURRENTLY DOING WELL.

  Patient problems: Visual Disturbances

  MAUDE report 24092584 ↗
• InjuryDec 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORT THAT 1-DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE EYE, THE PATIENT PRESENTED WITH HIGH INTRAOCULAR PRESSURE (IOP) AND HAD PAIN. AN ANTERIOR CHAMBER TAP WAS PERFORMED, THE PRESSURE CAME DOWN THE FOLLOWING DAY, AND THE PATIENT HAS NOT REPORTED ANY SYMPTOMS POST-TREATMENT. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED. THIS IS LENS #1 OF 2 FOR THIS PATIENT. REF:0001313525-2025-00215.

  Patient problems: Eye Pain; Intraocular Pressure Increased

  MAUDE report 23708067 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 3 MONTHS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE (OS), THE PATIENT COMPLAINED THEY NOTICED A DECREASE IN VISION; MENTIONING SEEING HALOS AND STARBURSTS AT NIGHT. UPON EXAMINATION, POSTERIOR CAPSULE OPACIFICATION (PCO) WAS OBSERVED AND A YAG LASER CAPSULOTOMY WAS PERFORMED TO TREAT THE PCO. APPROXIMATELY 6 MONTHS AFTER THE ONSET OF PROBLEM, THE IOL WAS EXCHANGED WITH A DIFFERENT MODEL IOL DUE TO UNRESOLVED SYMPTOMS. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT WAS THAT THE PATIENT WAS UNHAPPY WITH NIGHT VISION DUE TO DYSPHOTOPSIA FROM DIFFRACTIVE DESIGN OF THE IOL. PATIENT OUTCOME IS GOOD; VISION IMPROVED AFTER EXCHANGE.

  Patient problems: Blurred Vision; Halo; Posterior Capsule Opacification; Visual Disturbances

  MAUDE report 23704035 ↗
• 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 POOR VISION, TIGHT INCISIONS, 2+ FOLDS ENDOTHELIAL PRECIPITATES, 3-4+ CELL & FIBRIN AND 1MM HYPOPYON. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS MODERATE TOXIC ANTERIOR SEGMENT SYNDROME (TASS). TWO DAYS AFTER THE ONSET OF SYMPTOMS, A CULTURE WAS PERFORMED, BUT THE SAMPLE WAS UNUSABLE. IN SURGEON'S OPINION TASS WAS CAUSED BY THE IOL IMPLANT AND REPORTED NO OTHER CORRELATION CAN BE FOUND. PATIENT OUTCOME IS GOOD; THE EYE IS HEALING, AND VISUAL ACUITY IS IMPROVING. MEDICATIONS USED DURING ORIGINAL SURGERY: INTRACAMERAL INJECTION OF MOXIFLOXACIN. THE FOLLOWING MEDICATIONS WERE PRESCRIBED (FOR USE AT HOME POST-OPERATIVELY): PRED/MOXI/BROM 1GTT BOTH EYES QID UNTIL GONE ADDITIONAL MEDICATIONS (B)(6) 2025: PREDNISOLONE ACETATE TO BE USED OS Q1 HOUR ORAL STEROID PREDNISONE, DOSE PACK.

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

  MAUDE report 21892486 ↗
• InjuryApr 17, 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), 1-2+ CENTRAL FOLDS, 3-4+ CELL, 3-4+ FIBRIN, THICK FIBRIN COVERING ANTERIOR CAPSULE, AND POOR VIEW OF IOL WAS OBSERVED. AN AC TAP WAS PERFORMED FOR CULTURE. THE RESULTS WERE INCONCLUSIVE, NO GROWTH. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS THE IOL; STATING IT WAS AN ISOLATED CASE, WITH NO INDICATION WHERE IT CAME FROM. PATIENT OUTCOME IS GOOD. MEDICATION ADMINISTERED DURING ORIGINAL SURGERY: INTRACAMERAL MOXIFLOXACIN. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: PRED/MOXI/BROM 1GTT OU QID UNTIL GONE. PREDNISOLONE ACETATE 1% OS Q 1 HOUR. MEDROL DOSE PACK-ORAL PREDNISONE.

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

  MAUDE report 21859985 ↗