enVista® IOL MX60E (REF MXUE1900)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10757770531278), received between Feb 7, 2024 and Apr 25, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 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 HYPOPYON WITHOUT A DECREASE IN BEST CORRECTED VISUAL ACUITY (BCVA). BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT WAS REFERRED THE SAME DAY TO HAVE A VITREOUS TAP PERFORMED AND INJECTION ADMINISTERED. RESULTS OF THE CULTURE WERE NEGATIVE. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS UNCLEAR. PATIENT OUTCOME IS GOOD. MEDICATIONS ADMINISTERED DURING ORIGINAL SURGERY: MOXIFLOXACIN. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: TOPICAL STEROID DROPS.

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

  MAUDE report 21913343 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE ONE-DAY POST-OPERATIVE VISIT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE SURGEON NOTED THE PATIENT PRESENTED WITH 1-2+ EDEMA, SEIDEL SIGN, AND CELL 2+ FIBRIN IN AC. THIS REACTION WAS DIAGNOSED AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT'S BCVA DECREASED FROM 20/150 TO CF @ 1 FT. THE DAY AFTER SYMPTOMS WERE OBSERVED, AN INTRAVITREAL INJECTION OF VANCOMYCIN & CEFTAZIDIME WAS PERFORMED, AND A CULTURE WAS TAKEN. THE RESULT OF THE CULTURE WAS NEGATIVE. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF EVENT IS POSSIBLY FROM THE VISCO AND LIDO/PHEN. PATIENT OUTCOME IS GOOD. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POSTOPERATIVELY: PRED-MOXI-BROM 1%, .5%, 0.075% DOSE: 1GTT FREQUENCY: TID 2 WEEKS, BID 1 WEEK, QD 1 WEEK NEOMYCIN & POLYMYXIN & DEXAMETHASONE DOSE: 1 SMALL RIBBON FREQUENCY: ONCE PREDNISOLONE 1% DOSE:1GTT FREQUENCY: QHOURLY DURATION: UNTIL DIRECTED OTHERWISE

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

  MAUDE report 19940627 ↗
• InjuryFeb 7, 2024Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 6 WEEKS AFTER THE IMPLANTATION OF AN IOL INTO THE RIGHT EYE, THE IOL WAS EXPLANTED AND REPLACED WITH A LENS OF A SAME MODEL AND SLIGHTLY DIFFERENT DIOPTER DUE TO MECHANICAL COMPLICATION OF IOL. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 18659201 ↗