enVista Envy™ IOL (REF ENU2100)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10757770637277), received between Apr 14, 2025 and Jun 3, 2026 — classified as 6 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 9 DAYS AFTER THE IMPLANTATION OF A MULTIFOCAL INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD) THE PATIENT COMPLAINED OF HALOS AND BLURRY VISION. ABOUT THREE AND A HALF MONTHS AFTER SYMPTOM ONSET, THE INITIAL IOL WAS REMOVED AND REPLACED WITH A DIFFERENT MODEL LENS. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT WAS IOL COMPLICATIONS SPECIFICALLY GLARE AND HALOS. THE SURGEON REPORTS A SUCCESSFUL POST EXCHANGE OUTCOME.

  Patient problems: Blurred Vision; Halo

  MAUDE report 25377876 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD), THE PATIENT EXPERIENCED HALOS, REDUCED CONTRAST SENSITIVITY AND DIMINISHED COLOR VISION. THE PATIENT WAS TREATED WITH ARTIFICIAL TEARS, STEROID EYE DROPS, AND UNDERWENT A DIAGNOSTIC BRAIN MRI. DESPITE THESE INTERVENTIONS, THE PATIENT REQUESTED AN IOL EXCHANGE. APPROXIMATELY SEVEN MONTHS AFTER IMPLANTATION, THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL LENS. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT WAS MULTIFOCAL LENS INTOLERANCE. THE PATIENT'S OUTCOME IS GOOD.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 25375090 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL WAS INFORMATION RECEIVED FROM THE REPORTING FACILITY INDICATING THE PATIENT STILL HAS SLIGHTLY BLURRY VISION, BUT IT IS IMPROVING AND OUTCOME IS REPORTEDLY GOOD.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 25243693 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CLEAR LENS EXCHANGE PROCEDURE WITH IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE LEFT EYE (OS). APPROXIMATELY ONE WEEK POSTOPERATIVELY, THE PATIENT COMPLAINED OF HALOS AND GLARE. ABOUT THREE MONTHS AFTER SYMPTOM ONSET, THE INITIAL IOL WAS REMOVED AND REPLACED WITH A DIFFERENT MODEL LENS. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT WAS THE LENS. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 25242396 ↗
• InjuryApr 23, 2025Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information; Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT ONE DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED FIBRIN WHICH LED THEM TO BE DIAGNOSED WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT WAS REFERRED TO A RETINA SPECIALIST. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT RECEIVED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 21894428 ↗
• InjuryApr 14, 2025Patient Device Interaction Problem

  I HAD BAUSCH AND LOMB ENVISTA ENVY LENS IMPLANTS ON (B)(6) 2025. BOTH EYES HAD HIGH PRESSURE FOLLOWING SURGERY. THE SECOND SURGERY EYE (RIGHT) WAS MORE SIGNIFICANT THAN THE FIRST. IT RESULTED IN EXTREMELY HIGH EYE PRESSURE, DISTORTED VISION, HAVING TO BE PLACED ON ANOTHER EYE DROP TO BRING DOWN EYE PRESSURE (TWO PRESSURE REDUCING DROPS INITIALLY). REF REPORT: MW5168959.

  Patient problems: Intraocular Pressure Increased; Visual Impairment

  MAUDE report 21832611 ↗