enVista® Toric IOL MX60ET (REF MXUET425+190)Recalls & reported problems
Bausch & Lomb Incorporated · enVista one-piece hydrophobic acrylic toric intraocular lens +19.00D SE / +4.25D 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 10757770557131), received between Jan 25, 2024 and Jan 25, 2024 — classified as 1 injury.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Device Dislodged or Dislocated1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 25, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
IT WAS REPORTED THAT AFTER THE INSERTION OF AN IOL, INTO THE EYE, A PORTION OF THE IOL HAPTIC/OPTIC JUNCTION WAS BROKEN. THE SURGEON MADE THE DECISION TO LEAVE THE IOL IN THE EYE, BECAUSE IT SEEMED STABLE. APPROXIMATELY A WEEK AFTER THE IMPLANTATION, THERE WAS A FORTY-DEGREE ROTATION OF THE IOL. THE IOL WAS EXPLANTED AND REPLACED WITH A LENS OF THE SAME MODEL AND DIOPTER, 2 WEEKS POST-IMPLANTATION. IN THE SURGEON''S OPINION, THE PARTIALLY BROKEN OPTIC/HAPTIC JUNCTION MAY HAVE CAUSED THE IOL ROTATION. THE PATIENT OUTCOME IS GOOD.
Patient problems: Insufficient Information
MAUDE report 18584208 ↗
Other intraocular lens devices
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- 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.
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