enVista® Toric IOL MX60PT (REF MXUPT125+160)Recalls & reported problems
Bausch & Lomb Incorporated · enVista one-piece hydrophobic acrylic toric intraocular lens (preloaded) +16.00D SE / +1.25D CYL · Class 3 · Implant
All models of enVista Toric IOL (450)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10757770566348), received between Jul 10, 2025 and Jul 10, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Unintended Movement” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended Movement1
Patient problems
- Blurred Vision1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 10, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT APPROXIMATIVELY 2 MONTHS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE LENS WAS EXCHANGED WITH A DIFFERENT DIOPTER OF THE SAME MODEL LENS DUE TO THE INITIAL LENS BEING THE WRONG POWER AND ROTATING OUT OF POSITION. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS THAT THE LENS SHIFTED AND CHANGED AXIS OF THE LENS. FOUR DAYS POST EXCHANGE, IT WAS REPORTED THE PATIENT¿S VISION WAS STILL BLURRY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Blurred Vision
MAUDE report 22470387 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page