enVista® IOL EE (REF EEU1900)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10757770607850), received between Apr 18, 2025 and Apr 25, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2025Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information; Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT ON POST-OP DAY 1 THE PATIENT COMPLAINED OF SPIKING PAIN AND LIGHT SENSITIVITY. THE PATIENT PRESENTED WITH MODERATE CORNEAL EDEMA AND AT LEAST 3+ CELL IN THE ANTERIOR CHAMBER. AN ANTERIOR CHAMBER PARACENTESIS WAS PERFORMED, AND THE PATIENT WAS PRESCRIBED SIMBRINZA. LATER THAT DAY THE PATIENT REPORTED INCREASING PAIN, THE SURGEON PRESCRIBED METHAZOLAMIDE TO BE TAKEN ORALLY. THE FOLLOWING DAY THE PATIENT PRESENTED WITH MARKED EDEMA AND A HYPOPYON. BASED ON THE FINDINGS, THE SURGEON DETERMINED THE CAUSE OF THE EVENT TO BE EITHER TASS (TOXIC ANTERIOR SEGMENT SYNDROME) OR ENDOPHTHALMITIS. THE PATIENT WAS IMMEDIATELY REFERRED TO RETINA FOR A TAP AND INJECT TO BE PERFORMED. THE TAP DID NOT YIELD ANY GROWTH; THEREFORE, THE SURGEON CONCLUDED THE CAUSE OF THE EVENT TO BE TASS. APPROXIMATELY NINE DAYS LATER THE PATIENT UNDERWENT A VITRECTOMY WITH MEMBRANE STRIPPING, AC WASHOUT, AND KENALOG. AT ONE-MONTH POST-OP PATIENT PRESENTED WITH RELATIVE AFFERENT PUPILLARY DEFECT (RAPD), IRREGULAR IRIS, AND SOME FIBROSIS OVER THE LENS IMPLANT. PATIENT'S VISION IMPROVED SLIGHTLY TO 20/100-2 (PH 20/60-) & INTRAOCULAR PRESSURE (IOP) IMPROVED. THE PATIENT WAS LOS

  Patient problems: Corneal Edema; Eye Pain; Fibrosis; Hypopyon; Intraocular Pressure Increased; Iritis; Photophobia; Retinal Injury; Toxic Anterior Segment Syndrome (TASS); Visual Impairment

  MAUDE report 21913482 ↗
• InjuryApr 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ONE DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE PATIENT PRESENTED WITH DECREASED VISUAL ACUITY, CORNEAL EDEMA 2-3+, SUPERFICIAL PUNCTATE KERATITIS, TRACE EDEMA IN THE ANTERIOR CHAMBER (DEPTH 4+ AND CELLS 2+), AND THE IRIS HAD MILD FIBRIN STRANDS. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT WAS TREATED WITH PREDNISONE 50 MG DAILY FOR THREE DAYS AND PREDNISOLONE ACETATE EVERY TWO HOURS TILL TOLD TO DISCONTINUE. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT WAS THE IOL. PATIENT OUTCOME WAS REPORTED TO BE GOOD.

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

  MAUDE report 21894334 ↗
• InjuryApr 18, 2025Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information; Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT 1 DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE (OS), STRANDS OF FIBRIN + CELL WERE OBSERVED. THE PATIENT HAD A DECREASE IN BCVA. FINDINGS (B)(6) 2025: K-CLEAR, 2+ CELL AC. FINDINGS (B)(6) 2025: 4+ EPITH (MCE) - SEIDEL 2+ CELL. ON (B)(6) 2025 THE SURGEON ADMINISTERED DIAMOX 250MG AND BURPED THE WOUND. FINDINGS (B)(6) 2025: CONJ CLEAR, K-TRACE EDEMA, ABSENT EPITH MCE, - SEIDEL, AC 3+ CELL. PATIENT PROGNOSIS REPORTED AS UNKNOWN. ADDITIONAL INFORMATION REGARDING PATIENT PROGNOSIS WAS REQUESTED BUT NOT RECEIVED. MEDICATIONS USED DURING ORIGINAL SURGERY: INTRACAMERAL INJECTION-MOXIFLOXACIN 0.5%, XYLOCAINE 0.5% MPF, TETRACAIN 0.5% GTSS, VIGAMOX 0.05% GTSS. THE FOLLOWING MEDICATIONS WERE PRESCRIBED: PREDFORTE/MOXIFLOXACIN/BROMFENAC TID INCREASED TO QID ON (B)(6) 2025, TIMOLOL (B)(6) 2025), DIAMOX 500MG BID 1 DAY (B)(6) 2025).

  Patient problems: Corneal Edema; Intraocular Pressure Increased; Toxic Anterior Segment Syndrome (TASS); Visual Impairment

  MAUDE report 21866315 ↗
• 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 (OS), FIBRIN IN AC, 2+CELL, AND HYPOPYON ABOUT .5MM WAS OBSERVED. THE PATIENT'S BCVA DECREASED FROM 20/20 SC POD1 TO 20/60 SC POD2. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS TASS RELATED EVENT. PATIENT OUTCOME IS GOOD. THE FOLLOWING MEDICATIONS WERE PRESCRIBED (FOR USE AT HOME POST-OPERATIVELY): OMNI COMBO GTTS ONE DROP OS TID (B)(6) 2025), PRED FORTE 1% ONE DROP OS Q1HR (STARTED (B)(6) 2025), MOXIFLOXACIN 0.5% ONE DROP OS TID (STARTED (B)(6) 2025), KETOROLAC 0.4% ONE DROP OS QID-BID (STARTED (B)(6) 2025), MEDROL DOSE PACK.

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

  MAUDE report 21864782 ↗
• InjuryApr 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ONE DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE EYE, THE PATIENT BEGAN DEVELOPING BLURRY VISION. THE NEXT DAY, THE PATIENT PRESENTED WITH 4+ AC CELL, HYPOPYON, AND NO VIEW POSTERIORLY. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT WAS IMMEDIATELY REFERRED TO RETINA WHERE THEY INJECTED 2 ANTIBIOTICS AND DEXAMETHASONE. BY THE FOLLOWING DAY, THE HYPOPYON HAD RESOLVED AND THE PATIENT WAS BACK TO 20/40. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME PRE-OPERATIVELY & POSTOPERATIVELY: PF QID. KETOROLAC QID (STARTED 3 DAYS PRIOR TO SURGERY). MOXIFLOXACIN QID (STARTED 3 DAYS PRIOR TO SURGERY).

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

  MAUDE report 21864499 ↗