enVista® IOL EE (REF EEU2150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10757770607904), received between Jun 5, 2026 and Jun 5, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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-1679-2025 · 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.

• InjuryJun 5, 2026Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT ONE DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD), THE PATIENT HAD CLOUDY VISION AND FOREIGN BODY SENSATION IN THE OPERATED EYE. PER THE SURGEON THE LENS BECAME DISLOCATED. TWO DAYS POSTOPERATIVELY, A SECONDARY PROCEDURE WAS PERFORMED TO REPOSITION THE IOL WITH NO SUCCESS. APPROXIMATELY ONE WEEK POST ORIGINAL IMPLANT, THE IOL WAS REMOVED AND REPLACED WITH A DIFFERENT MODEL LENS. THE PATIENT SUBSEQUENTLY EXPERIENCED POSTOPERATIVE INFLAMMATION WHICH WAS TREATED WITH STEROID/ANTIBIOTICS DROPS AS EXPECTED AND CONSISTENT WITH THE STANDARD COURSE OF MULTIPLE PROCEDURES.

  Patient problems: Blurred Vision; Foreign Body Sensation in Eye; Swelling/ Edema

  MAUDE report 25414130 ↗