enVista Envy™ IOL (REF ENU2250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10757770637307), received between Apr 18, 2025 and Sep 30, 2026 — classified as 4 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-1680-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that approximately four months post intraocular lens (IOL) implantation in the right eye, the lens was explanted due to the patient experiencing glares and halos. A back up lens of a different model was placed.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 50944761 ↗
• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that approximately 9 months after implantation of an intraocular lens (IOL) in the right eye (OD), the lens was explanted.This report is for the right eye (OD). Left eye (OS) reference: 0001313525-2026-00124.

  Patient problems: Insufficient Information

  MAUDE report 50429030 ↗
• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED EIGHT DAYS AFTER A MULTIFOCAL LENS (IOL) WAS PLACED IN THE PATIENTS LEFT EYE (OS) THE PATIENT FELT THEIR QUALITY OF VISION AND COLOR VISION WAS POOR. APPROXIMATELY NINE WEEKS AFTER THE LENS WAS INITIALLY PLACED IT WAS EXPLANTED AND REPLACED FOR A DIFFERENT MODEL LENS. THE SURGEON CITES PATIENT DISSATISFACTION AS THE ISSUE WITH A GOOD POST EXCHANGE OUTCOME.

  Patient problems: Visual Disturbances

  MAUDE report 25898719 ↗
• InjuryApr 18, 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 INCREASED ANTERIOR CHAMBER CELLS & FIBRIN. PATIENT'S BCVA DID NOT DECREASE. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS RELATED TO IOL STORAGE MEDIA. PATIENT OUTCOME IS GOOD. THE FOLLOWING MEDICATIONS WERE PRESCRIBED (FOR USE AT HOME POST-OPERATIVELY): TOBRADEX 1 GTT EVERY HOUR, ZYMAMID 1 GTT EVERY HOUR, AVELOX 400G QD 1 WEEK.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 21864665 ↗