enVista® IOL MX60E (REF MXUE2250)Recalls & reported problems
Bausch & Lomb Incorporated · enVista one-piece hydrophobic acrylic intraocular lens +22.50D · Class 3 · Implant
All models of enVista IOL (74)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10757770531414), received between Dec 20, 2023 and Sep 8, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Break” (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 Problem2
- Break1
- Device Dislodged or Dislocated1
Patient problems
- Insufficient Information2
- Capsular Bag Tear1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT APPROXIMATELY 3 YEARS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE LENS WAS REMOVED, A VITRECTOMY WAS PERFORMED, AND A DIFFERENT MODEL IOL WAS IMPLANTED. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS THE LENS DISLODGED.
Patient problems: Insufficient Information
MAUDE report 22993485 ↗InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATIVELY 17 MONTHS AFTER THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL IOL DUE TO DYSPHOTOPSIAS. REPORTEDLY, THE PATIENT NOTICED A DECREASE IN VISION, COMPLAINING OF SHADOWS TEMPORALLY. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT WAS DYSPHOTOPSIA. PATIENT OUTCOME IS GOOD.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 21357659 ↗InjuryApr 23, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED INDICATING AN ANTERIOR CAPSULAR TEAR OCCURRED PRIOR TO INSERTION OF THE INTRAOCULAR LENS.
Patient problems: Insufficient Information
MAUDE report 19167122 ↗InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE CAPSULAR BAG COLLAPSED WHEN THE LENS WAS PLACED INTO THE EYE. THE IOL WAS REMOVED, AND A BACKUP LENS OF A DIFFERENT MODEL WAS SUCCESSFULLY IMPLANTED. THE PATIENT OUTCOME IS GOOD.
Patient problems: Capsular Bag Tear
MAUDE report 18368119 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- 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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