enVista Envy™ IOL (REF ENU1950)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10757770637253), received between Mar 4, 2026 and Jul 16, 2026 — classified as 3 injuries.

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-1680-2025 · 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.

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

  IT WAS REPORTED THAT APPROXIMATELY 7 MONTHS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD), THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL LENS DUE UNRESOLVED GLARE AND HALOS. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT WAS THE PATIENT'S INABILITY TO NEUROADAPT TO THE TRIFOCAL IOL. PATIENT OUTCOME IS GOOD, AND THE PATIENT IS EXPERIENCING LESS DYSPHOTOPSIA WITH THE REPLACEMENT IOL. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 25846408 ↗
• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE PATIENT¿S LEFT EYE (OS), THE PATIENT COMPLAINED OF VISUAL DISTURBANCES INCLUDING DOUBLING AND SHADOWING OF LETTERS AND LIGHTS, LIGHT RELATED GLARE AND HALOS, AND GHOSTING OF OBJECTS SUCH AS CARS. APPROXIMATELY THREE MONTHS AFTER SYMPTOM ONSET, THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF EVENT WAS VISUAL DISTURBANCE WITH THE MULTIFOCAL IOL. THE PATIENT HAS SINCE RECOVERED. THIS IS THE REPORT FOR THE LEFT EYE (OS). RIGHT EYE (OD) REFERENCE: 0001313525-2026-00088.

  Patient problems: Diplopia/Double Vision; Halo; Photophobia; Visual Disturbances

  MAUDE report 25612183 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  A SURGERY CENTER REPORTED THAT A PATIENT HAD TWO IOL¿S EXPLANTED DUE TO MALADAPTATION TO MULTIFOCAL INTRAOCULAR LENS (IOL). A LAL+ IOL FROM A DIFFERENT MANUFACTURER WAS IMPLANTED. THIS REPORT IS FOR IOL 1 OF 2.

  Patient problems: Visual Impairment

  MAUDE report 24512868 ↗