enVista® IOL EE (REF EEU2000)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10757770607874), received between Apr 23, 2025 and Jun 2, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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-1679-2025 · 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.

• InjuryJun 2, 2026Break

  IT WAS REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE HAPTIC WAS TORN. THE INCISION WAS ENLARGED AND A DIFFERENT MODEL IOL WAS IMPLANTED. A SUTURE WAS USED TO HELP CLOSE THE WOUND. POST OPERATIVELY THE PATIENT WAS DIAGNOSED WITH CORNEAL EDEMA AND INFLAMMATION, HOWEVER ACCORDING TO THE SURGEON THE PATIENT IS IMPROVING. IN THE SURGEON¿S OPINION THE MOST LIKELY CAUSE OF THE EVENT IS THE MANNER LENS WAS LOADED INTO THE CARTRIDGE BY THE SCRUB TECH.

  Patient problems: Corneal Edema; Inflammation

  MAUDE report 25368664 ↗
• InjuryJul 31, 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 TRACE EDEMA AND ANTERIOR CHAMBER FIBERING 4-5+ CELLS. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). A TAP & INJECT WAS PERFORMED BY A RETINA SPECIALIST THE SAME DAY FOR VITRITIS. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF EVENT WAS TASS-ENDOPHTHALMITIS. PATIENT OUTCOME REPORTED AS VISUAL ACUITY OF 20/30-2. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: OFOXIN 1 DROP EVERY 2 HOURS. PREDNISOLONE 1 DROP EVERY 2 HRS 3+ MONTHS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Swelling/ Edema; Toxic Anterior Segment Syndrome (TASS); Vitritis

  MAUDE report 22675389 ↗
• InjuryJun 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT TWO DAYS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE PATIENT COMPLAINED OF BLURRY VISION, PHOTOPHOBIA, PAIN, AND EYE REDNESS/IRRITATION. SLIT LAMP FINDINGS WERE CORNEAL EDEMA, DIFFUSE D FOLDS, 2-3+ CELL/FLARE, AND FIBRIN/OPACITY COVERING IOL. THE PATIENT¿S BEST CORRECT VISUAL ACUITY (BCVA) DECREASED FROM 20/50 TO 20/150. THE PATIENT WAS RE-EDUCATED ON EYE DROP ADMINISTRATION AND COMPLIANCE AND CLOSELY MONITORED OVER NEXT FEW WEEKS AND DID NOT SHOW MUCH IMPROVEMENT. APPROXIMATELY ONE MONTH AFTER THE ONSET OF SYMPTOMS, A VITREOUS TAP WAS PERFORMED, AND INJECTIONS OF VANCOMYCIN, CEFTAZIDIME AND DEXAMETHASONE WERE ADMINISTERED. THE PATIENT WAS PRESCRIBED ORAL STEROIDS. THE CULTURE HAD NO GROWTH. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS UNCLEAR, BUT FAVORS TASS, STATING THAT THE FINDINGS WERE INCONSISTENT WITH INFECTIOUS ENDOPHTHALMITIS VS. ROBUST INFLAMMATORY RESPONSE WITH CYSTOID MACULAR EDEMA. PATIENT HAS PERSISTENT MACULAR EDEMA AND CORNEAL EDEMA/DESCEMET'S FOLDS. MEDICATIONS PRESCRIBED FOR USE AT HOME POST-OPERATIVE

  Patient problems: Blurred Vision; Corneal Edema; Eye Irritation; Eye Pain; Macular Edema; Photophobia; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 22331520 ↗
• InjuryApr 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE PATIENT PRESENTED THE SAME DAY WITH MODERATE INJECTION (DIFFUSE), 2+ EDEMA, SEVERE DIFFUSE SUPERFICIAL PUNCTATE KERATITIS (SPK), 1+ FLARE, 1+CELL. BASED ON THE FINDINGS, THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS THE IOL. PATIENT OUTCOME IS GOOD. MEDICATIONS ADMINISTERED DURING ORIGINAL SURGERY: KENALOG & MOXIFLOXACIN. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: TYLENOL, PRN. PROLENSA 0.07%, 1 GTT QD 4 WEEKS. DIFLUPREDNATE 0.05%, 1 GTT EVERY HOUR.

  Patient problems: Intraocular Pressure Increased; Swelling/ Edema; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 21903102 ↗
• InjuryApr 24, 2025Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information; Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT 4 DAYS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE (OS), THE PATIENT COMPLAINED OF PAIN, DISCOMFORT, SENSITIVITY TO LIGHT & FOGGY VISION. INJECTIONS OF CEFTAZIDIME (2MG/0.1ML) & VANCOMYCIN (1MG/0.1ML) WERE ADMINISTERED AND A CULTURE WAS TAKEN. THE RESULTS OF THE CULTURE WERE NEGATIVE. PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) DECREASED IMMEDIATELY POST-OP AND THROUGHOUT INTERVENTION BUT RESOLVED AFTER. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS LENS MATERIAL. PATIENT OUTCOME IS GOOD. THE FOLLOWING MEDICATION WAS PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: OFLOXACIN.

  Patient problems: Eye Pain; Photophobia; Toxic Anterior Segment Syndrome (TASS); Visual Impairment

  MAUDE report 21899988 ↗
• InjuryApr 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT FOUR DAYS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE PATIENT PRESENTED WITH DECREASED VISION AND SEVERE ANTERIOR CHAMBER INFLAMMATION AND SYSTEMIC RASH. SLIT LAMP FINDINGS WERE 3+ CORNEAL EDEMA, 2MM HYPOPYON AND FIBRIN ON IOL. PATIENT'S BCVA DECREASED. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). PATIENT WAS TREATED WITH INTRAVITREAL ANTIBIOTICS AND TOPICAL STEROIDS. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS TASS OR ENDOPHTHALMITIS. THE PATIENT IS RECOVERING AND CONTINUES TO MAKE IMPROVEMENTS IN VISION AS CORNEAL EDEMA AND VITRITIS IMPROVE. THE FOLLOWING MEDICATIONS WERE PRESCRIBED (FOR USE AT HOME POST-OPERATIVELY): PREDNISOLONE AND OFLOXACIN

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

  MAUDE report 21895096 ↗
• InjuryApr 23, 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, THE PATIENT PRESENTED WITH DECREASED VISUAL ACUITY, CORNEAL EDEMA 1+, ANTERIOR CHAMBER CELL 4+ FIBRIN, FLARE TRACE AND FLARE 4+ 1 MM HYPOPYON AND THE IRIS HAD FIBRIN WITHIN THE PUPIL. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT WAS TREATED WITH ORAL PRED 50 MG DAILY 3X A DAY AND PREDNISOLONE DROPS, 1 DROP, EVERY HOUR WHILE AWAKE. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS THE IOL. PATIENT OUTCOME WAS REPORTED TO BE GOOD.

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

  MAUDE report 21894308 ↗