EnVista MX60 IOL MX60TP275+130Recalls & reported problems
Bausch & Lomb Incorporated · MX60TP275 12.5MM +13.0 · Class 3 · Implant
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 10757770517487), received between Apr 17, 2024 and Apr 17, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Eject” (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
- Failure to Eject1
- Insufficient Device Problem Information1
Patient problems
- Capsular Bag Tear1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2024Insufficient Device Problem Information; Failure to Eject; Insufficient Device Problem Information; Failure to Eject
IT WAS REPORTED THAT DURING A CATARACT SURGERY THE INTRAOCULAR LENS WAS STUCK IN THE INJECTOR. THE INJECTOR WAS REMOVED FROM THE EYE, THE IOL WAS REMOVED FROM THE INJECTOR AND TRANSFERRED TO ANOTHER INJECTOR OF A DIFFERENT MODEL. DURING THE IMPLANTATION WITH THE REPLACEMENT INJECTOR A RUPTURED POSTERIOR CAPSULE WAS OBSERVED. AN ANTERIOR VITRECTOMY WAS PERFORMED TO REMOVE THE VITREOUS. THE MAIN INCISION WAS ENLARGED BEFORE THE IOL IMPLANTATION. THE LENS REMAINS IMPLANTED IN THE EYE AND A FOLLOW-UP APPOINTMENT IS PLANNED TO CHECK THAT THE LENS IS IN THE CORRECT POSITION. ALTHOUGH REQUESTED ADDITIONAL INFORMATION WAS NOT OBTAINED.
Patient problems: Capsular Bag Tear
MAUDE report 19123076 ↗
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.
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