enVista Envy™ IOL (REF ENU2300)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10757770637314), received between Mar 18, 2026 and Aug 25, 2026 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 left eye (OS), the lens was explanted.This report is for the left eye (OS). Right eye (OD) reference: (b)(4).

  Patient problems: Insufficient Information

  MAUDE report 50428792 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE FACILITY REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S LEFT EYE, THE PATIENT REPORTED THEIR VISION WAS GRAYED OUT AND CLOUDY. DESPITE ACHIEVING UNCORRECTED VISUAL ACUITY OF 20/20 AND J1, THE PATIENT REPORTED INADEQUATE FUNCTIONAL VISION. TWO MONTHS LATER, THE SURGEON PERFORMED AN IOL EXCHANGE FOR A NON-MULTIFOCAL IOL DUE TO THE PATIENT EXPERIENCING CONTRAST ISSUES. THE PATIENT HAS CLEARER VISION POST LENS EXCHANGE.

  Patient problems: Visual Disturbances

  MAUDE report 24632924 ↗