enVista® IOL MX60E (REF MXUE2050)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10757770531339), received between Aug 8, 2024 and Apr 17, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2026Particulates

  THE HEALTHCARE FACILITY REPORTED AN AC WASHOUT (ANTERIOR CHAMBER) WAS REQUIRED TWO (2) MONTHS AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION. IT WAS ORIGINALLY THOUGHT TO BE RETAINED CAPSULORHEXIS AT 3PM POSITION, EXTENDING THROUGH AC CLOSE TO ENDOTHELIUM. AFTER ASSESSMENT BY THE SURGEON IT WAS FOUND TO BE OF FOREIGN BODY APPEARANCE. AT FOLLOW-UP ONE WEEK POST AC WASHOUT, THE PATIENT DID NOT NOTE ANY SYMPTOMS AND WAS HAPPY WITH THE OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 24912616 ↗
• InjuryJun 2, 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 COMPLAINED OF PAIN AND BLURRY VISION, WHICH PROGRESSED DAY 2. SLIT LAMP FINDINGS ON POST-OP DAY 2 WERE CORNEAL EDEMA 4+, C/S INJECTION 4+, AC CELL 3+, VITREOUS HAZE, VITREOUS CELLS 3+, AND VITRITIS 2+. THE PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) DECREASED FROM 20/30+ (PRE-OP) TO HAND MOTION. BASED ON THE FINDINGS, IT WAS PRESUMED TO BE EARLY STAPH ENDOPHTHALMITIS. AN INTRAVITREAL TAP/CULTURE WAS PERFORMED & INJECTIONS OF CEFTAZIDIME, VANCOMYCIN AND DEXAMETHASONE WERE ADMINISTERED. RESULTS OF THE CULTURE WERE NEGATIVE. THE PATIENT OUTCOME IS GOOD. ACCORDING TO THE DOCTOR, THE MOST LIKELY CAUSE OF THE EVENT IS TOXIC ANTERIOR SEGMENT SYNDROME. MEDICATIONS PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: PRED FORTE Q1H DAYTIME FOR 1 WEEK VIGAMOX QID. PROLENSA (DIRECTED TO DISCONTINUE USE (B)(6) 2024). LOTEMAX (DIRECTED TO DISCONTINUE USE (B)(6) 2024).

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

  MAUDE report 22127156 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 2 MONTHS AFTER THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL IOL DUE TO NEGATIVE DYSPHOTOPSIA. REPORTEDLY, THERE WAS NO DECREASE IN VISION. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS LIKELY RELATED TO IOL EDGE. PATIENT OUTCOME IS GOOD. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.

  Patient problems: Visual Disturbances

  MAUDE report 20192022 ↗
• 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 LEFT EYE, THE SURGEON NOTED THE PATIENT PRESENTED WITH 1+ EDEMA, 4+ FIBRIN, AND TRACE SLIVER OF HYPOPYON. THIS REACTION WAS DIAGNOSED AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). 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: NEOMYCIN & POLYMYXIN & DEXAMETHASONE DOSE: 1 SMALL RIBBON FREQUENCY: ONCE PRED-MOXI-BROM 1%, .5%, 0.075% DOSE: 1GTT FREQUENCY: TID 2 WEEKS, BID 1 WEEK, QD 1 WEEK DUREZOL DOSE: 1GTT FREQUENCY: QHOURLY DURATION: TILL DIRECTED OTHERWISE MOXIFLOXACIN DOSE: 1GTT FREQUENCY: QHOURLY DURATION: TILL DIRECTED OTHERWISE.

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

  MAUDE report 19940055 ↗