enVista Envy™ IOL (REF ENU1750)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10757770637215), received between May 19, 2025 and May 19, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Material Integrity Problem” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT APPROXIMATELY 4 WEEKS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE PATIENT COMPLAINED OF POOR VISION AND STATED HE FELT LIKE HIS RIGHT EYE WAS SEEING UNDERWATER. UPON EVALUATION THE SURGEON NOTICED A SLIGHT IRREGULARITY OR POSSIBLE OPTICAL ABERRATION IN THE CENTRAL OPTIC OF THE LENS DESCRIBED AS A SLIGHT DENT THAT IN HIS OPINION WAS IMPACTING THE PATIENT'S VISION. THE LENS WAS EXCHANGED, APPROXIMATELY TWO WEEKS LATER WITH A DIFFERENT MODEL IOL, AND PATIENT OUTCOME POST EXCHANGE IS REPORTED AS GOOD.

  Patient problems: Visual Disturbances

  MAUDE report 22048826 ↗