enVista Envy™ IOL (REF ENU2150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10757770637284), received between Mar 26, 2025 and Sep 9, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported approximately 4 months after a multifocal IOL was placed in the patients Left eye (OS) the lens was explanted and replaced with a monofocal IOL due to the patient reporting difficulty while driving at night due to circles in visual field while driving at night. Additional information regarding this event was requested but never received.

  Patient problems: Visual Disturbances

  MAUDE report 50691674 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOUR DAYS POST INTRAOCULAR LENS (IOL) IMPLANTATION IN THE RIGHT EYE, THE PATIENT REPORTED EXPERIENCING FOREIGN BODY SENSATION, VISUAL DISTURBANCES SUCH AS SHADOWS IN PERIPHERY WITH SEVERE GLARE AND HALOS AT NIGHT AND FEELING IMBALANCED. AFTER ONE MONTH OF DRY EYE TREATMENT THE PATIENT DID NOT IMPROVE; THEREFORE THE LENS WAS EXPLANTED. AN IOL OF A DIFFERENT MODEL WAS IMPLANTED AND THE PATIENTS CURRENT PROGNOSIS IS REPORTED TO BE GOOD.

  Patient problems: Foreign Body Sensation in Eye; Halo; Visual Disturbances

  MAUDE report 25442652 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  A SURGERY CENTER REPORTED THAT FOLLOWING IMPLANTATION OF THE INTRAOCULAR LENS (IOL), THE PATIENT EXPERIENCED NIGHTTIME DRIVING DIFFICULTIES AND HALOS. THE IOL WAS SUBSEQUENTLY EXCHANGED FOR THE SAME MODEL AND POWER. ACCORDING TO THE SURGEON, THE MOST LIKELY CAUSE OF THE SYMPTOMS WAS DYSPHOTOPSIA RELATED TO VISUAL DISTURBANCES FROM THE IOL.

  Patient problems: Halo; Visual Impairment

  MAUDE report 24706485 ↗
• InjuryApr 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE (OS), THE PATIENT PRESENTED WITH 4+ CELL IN ANTERIOR CHAMBER WITH SMALL STERILE HYPOPYON. THE PATIENT NOTICED THE PROBLEM WITHIN A WEEK POST-OP, WITH BEST CORRECTED VISUAL ACUITY (BCVA) DECREASING TO 20/60. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS TASS. PATIENT OUTCOME IS GOOD, WITH UNCORRECTED VISUAL ACUITY OF 20/25. 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) AND PRED FORTE Q 1 HR ALTERNATING OS MEDROL DOSE PACK ORAL..

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

  MAUDE report 21908552 ↗
• InjuryApr 24, 2025Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information; Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE PATIENT PRESENTED WITH INFLAMMATION. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT WAS TREATED WITH TOPICAL STEROID/ANTIBIOTICS/NSAIDS. TEN DAYS AFTER IMPLANTATION THE SURGEON REPORTED CORNEAL HAZE, STATING THE PATIENT WAS IMPROVING WITH VISUAL ACUITY AT LAST APPOINTMENT OF 20/50 AND DECREASE IN INFLAMMATION. THE FOLLOWING DAY, VISUAL ACUITY WAS MEASURED AT 20/30, AND THE SURGEON REPORTED THE PATIENT WAS WELL ON WAY TO RECOVERY. A WEEK AND A HALF LATER, THE SURGEON REPORTED THE ISSUE RESOLVED AND THE PATIENT IS SEEING 20/20 J1. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT WAS THE LENS. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: PRED/MOXI/PROLENSA. A MONTH AFTER THE LAST UPDATE WAS RECEIVED FROM THE SURGEON, THE CONSUMER REPORTED AN ADDITIONAL FINDING OF SECONDARY MACULAR EDEMA, STATING SHE WAS REFERRED TO A RETINA SPECIALIST AND HAD INJECTION(S) OF AVASTIN ADMINISTERED. ALLEGEDLY, VISION IS COMING BACK A LITTLE AFTER THE INJECTIONS.

  Patient problems: Corneal Clouding/Hazing; Macular Edema; Toxic Anterior Segment Syndrome (TASS); Unspecified Eye / Vision Problem

  MAUDE report 21903295 ↗
• InjuryApr 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 1-DAY POST-IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE PATIENT PRESENTED WITH LAYERED HYPOPYON, FIBRIN IN AC, AND MINIMAL CORNEAL EDEMA. INTRAVITREAL INJECTIONS OF CEFTAZIDIME AND VANCOMYCIN WERE ADMINISTERED, AND A CULTURE WAS TAKEN FOR SUSPECTED ENDOPHTHALMITIS. RESULTS OF THE CULTURE WERE NEGATIVE. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). PATIENT OUTCOME IS GOOD. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POSTOPERATIVELY: COMPOUND PREDNISOLONE 1%, MOXIFLOXACIN 0.5%, NEPAFENAC 0.1% 1 GTT QID X 1 WEEK TAPERING WEEKLY FOR 4 WEEKS. PREDNISOLONE 1% 1GTT QID ALTERNATING WITH COMBO DROP. TAPER SCHEDULE.

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

  MAUDE report 21864999 ↗
• InjuryApr 17, 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 3+ ANTERIOR CHAMBER CELLS. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT WAS TREATED WITH MOXIFLOXACIN, PRED, AND BROMFENAC FOUR TIMES A DAY FOR 1 WEEK AND PREDACETATE 1% EVERY TWO HOURS FOR 1 WEEK. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS TASS. PATIENT OUTCOME IS REPORTED TO BE GOOD.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 21853182 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 6 WEEKS AFTER THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL IOL DUE TO GLARE AND DYSPHOTOPSIA.

  Patient problems: Visual Disturbances

  MAUDE report 21694582 ↗