enVista® IOL MX60E (REF MXUE2500)Recalls & reported problems
Bausch & Lomb Incorporated · enVista one-piece hydrophobic acrylic intraocular lens +25.00D · Class 3 · Implant
All models of enVista IOL (74)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10757770531513), received between Apr 9, 2024 and Apr 23, 2025 — classified as 2 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Swelling/ Edema1
- Toxic Anterior Segment Syndrome (TASS)1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THREE DAYS AFTER AN IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE LEFT EYE, THE PATIENT WAS SUSPECTED OF HAVING TOXIC ANTERIOR SEGMENT SYNDROME (TASS) OR ENDOPHTHALMITIS. SLIT LAMP FINDINGS WERE 0.5MM HYPOPYON, 4+CELL IN AC, POSTERIOR VITREOUS QUIET, CORNEAL AND EPI-DEFECT. A VITRECTOMY WAS PERFORMED AND INTRAOCULAR INJECTIONS OF ANTIBIOTICS WERE ADMINISTERED. THE PATIENT'S BCVA DECREASED DUE TO POST-OP SWELLING AND REACTION TO TASS. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS TASS OR ENDOPHTHALMITIS. THE PATIENT'S OUTCOME IS GOOD. THE FOLLOWING MEDICATIONS WERE PRESCRIBED (FOR USE AT HOME POST-OPERATIVELY): SYMBRENZA, VIGAMOX, PROLENSA, DUREZOL AND MOXIFLOXACIN WERE GIVEN POSTOPERATIVELY.
Patient problems: Swelling/ Edema; Toxic Anterior Segment Syndrome (TASS)
MAUDE report 21896620 ↗InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED NINE MONTHS AFTER ORIGINAL IMPLANT OF AN INTRAOCULAR LENS (IOL) INTO THE EYE, A LENS EXCHANGE USING A DIFFERENT MODEL LENS AND DIOPTER WAS COMPLETED DUE TO PERSISTENT POSITIVE DYSPHOTOPSIA. DYSPHOTOPSIA RESOLVED WITH LENS EXCHANGE AND THE PATIENT'S PROGNOSIS IS EXCELLENT. IN THE SURGEON'S OPINION, DYSPHOTOPSIA IS SECONDARY TO ACRYLIC IOL. IT IMPROVED/RESOLVED WITH EXCHANGE TO SILICONE OPTIC MATERIAL.
Patient problems: Visual Disturbances
MAUDE report 19071616 ↗
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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