enVista® IOL MX60E (REF MXUE2300)Recalls & reported problems
Bausch & Lomb Incorporated · enVista one-piece hydrophobic acrylic intraocular lens +23.00D · 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 10757770531438), received between Feb 23, 2023 and Jan 17, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Material Opacification” (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 Problem3
- Material Opacification1
Patient problems
- Capsular Bag Tear2
- Insufficient Information2
- Visual Disturbances1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATIVELY ONE MONTH 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, THERE WAS NO DECREASE IN VISION. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT WAS THE ACRYLIC MATERIAL OF THE IOL.
Patient problems: Visual Disturbances
MAUDE report 21180479 ↗InjuryApr 9, 2024Material Opacification; Material Opacification
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT HAD PRE-EXISTING DIABETIC RETINOPATHY.
Patient problems: Insufficient Information
MAUDE report 19070654 ↗InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DUE TO A CAPSULE TEAR IN THE RIGHT EYE, THE INTRAOCULAR LENS (IOL) WAS REPLACED WITH A DIFFERENT MODEL AND DIOPTER IOL. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Capsular Bag Tear; Insufficient Information
MAUDE report 18655796 ↗InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REPORTEDLY, A POSTERIOR CAPSULE TEAR WAS OBSERVED DURING IMPLANT. THE IOL WAS REMOVED AND A THREE PIECE LENS WAS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: Capsular Bag Tear
MAUDE report 16428189 ↗
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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