enVista Envy™ IOL (REF ENU2200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10757770637291), received between Apr 18, 2025 and Sep 23, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that approximately five months after implantation of an intraocular lens (IOL) in the right eye (OD), the IOL was exchanged with a different model lens due to unresolved dysphotopsia and mechanical complication of the IOL. Additional information was requested but not received.

  Patient problems: Visual Disturbances

  MAUDE report 50867405 ↗
• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that approximately six months after implantation of an intraocular lens (IOL) in the patient's dominant right eye (OD), the lens was exchanged with a different model due to persistent halos experienced during both daytime and nighttime conditions. Prior to the lens exchange, the surgeon attempted to manage the symptoms by treating the patient's dry eye; however, the halos remained unresolved. In the surgeon's opinion, the most likely cause of the event was the patient's visual system/brain inability to tolerate halo phenomena associated with multifocal IOLs, noting that such symptoms can occur with all multifocal lenses. Additional information was requested but not received.

  Patient problems: Halo

  MAUDE report 50438925 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  RECEIVED ADDITIONAL INFORMATION, THE PATIENTS PROGNOSIS IS SUBJECTIVE VISUAL DISTURBANCE.

  Patient problems: Visual Disturbances

  MAUDE report 25253865 ↗
• InjuryAug 19, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ONE DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE PATIENT PRESENTED WITH FIBRIN, HYPOPYON AND 3T CELL. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). A RETINA SPECIALIST ADMINISTERED INTRAVITREAL INJECTION OF VANCOMYCIN/CEFTAZIDIME ON THE SAME DAY. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS TASS LIKELY FROM THE IOL. PATIENT OUTCOME IS GOOD. THE TASS RESOLVED AFTER TREATMENT. THE FOLLOWING MEDICATIONS WERE PRESCRIBED (FOR USE AT HOME POST-OPERATIVELY): PMB(PRED/MOXI/BROM) 1%/.05%/0.075% TID FOR 1 WEEK, THEN ONCE A DAY FOR 3 WEEKS.

  Patient problems: Hypopyon; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 22842545 ↗
• InjuryApr 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 1-DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE PATIENT PRESENTED WITH 3+ CELL WITH HYPOPYON. PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) DECREASED TO 20/80. IT WAS PRESUMED TO BE BACTERIAL ENDOPHTHALMITIS, A CULTURE WAS PERFORMED TO IDENTIFY THE CAUSE. RESULTS OF THE CULTURE WERE NEGATIVE, CONFIRMING THE EVENT WAS TOXIC ANTERIOR SEGMENT SYNDROME (TASS), NOT ENDOPHTHALMITIS. AT 3 DAYS POST-OP A VITRECTOMY WAS PERFORMED, AND AN INTRAVITREAL INJECTION OF VANCOMYCIN/CEFTAZIDIME WAS ADMINISTERED. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS SOMETHING IN THE PACKAGING CAUSING TASS. PATIENT OUTCOME IS GOOD. MEDICATIONS ADMINISTERED DURING ORIGINAL SURGERY: INTRACAMERAL MOXIFLOXACIN THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: COMBO DROP (PREDNISOLONE SODIUM PHOSPHATE-MOXIFLOXACIN-BROMFENAC-STERILE OPHTHALMIC SOLUTION) 1 DROP TWICE A DAY.

  Patient problems: Hypopyon; Toxic Anterior Segment Syndrome (TASS); Visual Impairment

  MAUDE report 21903388 ↗
• InjuryApr 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ONE DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE PATIENT PRESENTED WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT'S BCVA DECREASED AT DAY 1 POST OP TO 20/200. SLIT LAMP FINDINGS WERE DIFFUSE 1+ D-FOLDS (LIMBUS TO LIMBUS), 4+ CELL, PUPILLARY FIBRIN MEMBRANE. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS TASS SECONDARY TO IOL. THE PATIENT CONTINUES TO RECOVER AND HAS COMPLAINTS OF "FILM" IN THE LEFT EYE COMPARED TO THE RIGHT EYE. THE RIGHT EYE HAD AN IOL IMPLANTED ONE WEEK PRIOR AND HAS DONE WELL. THE FOLLOWING MEDICATIONS WERE PRESCRIBED (FOR USE AT HOME POST-OPERATIVELY): PRED/MOXI/BROMFENAC, ORAL PRED, ATROPINE AND DUREZOL.

  Patient problems: Blurred Vision; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 21903197 ↗
• InjuryApr 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 1 DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE PATIENT PRESENTED WITH BLURRED VISION, 3+ CELL, FIBRIN IN THE ANTERIOR CHAMBER WITH TRACK TO WOUND. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT WAS TREATED WITH PREDFORTE, MOXIFLOXACIN, AND BROMFENAC COMBO 1 DROP 4 TIMES A DAY FOR 1 WEEK, PREDACETATE 1 DROP EVERY HOUR FOR 2 DAYS, AND A MEDROL PACK PER INSTRUCTIONS. THE PATIENT WAS REFERRED TO A RETINA SPECIALIST FOR FURTHER TREATMENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 21865516 ↗