EnVista MX60 IOL MX60P2200Recalls & reported problems
Bausch & Lomb Incorporated · MX60P 12.5MM +22.00 · 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 10757770515537), received between Apr 3, 2026 and Apr 3, 2026 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Endophthalmitis1
- Hypopyon1
- Intraocular Pressure Increased1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
A SURGEON REPORTED THAT 1 DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE (OS) OF A PATIENT ENDOPHTHALMITIS OCCURRED IN THE OPERATED EYE. AT THE ONE-DAY POST OP SLIT LAMP FINDINGS THE SURGEON NOTED HYPOPYON, AC CELLS AND FLARE, A DECREASE IN PATIENTS BCVA. INITIAL TREATMENT CONSISTED OF TOPICAL MOXIFLOXACIN AND PREDNISONE ACETATE. TWO DAYS AFTER THE INITIAL PROCEDURE THE PATIENT HAD AN ELEVATED IOP OF 36MMHG. THREE DAYS AFTER THE LENS WAS INITIALLY PLACED A VITRECTOMY WAS PERFORMED. CULTURE AND SENSITIVITY PERFORMED WAS POSITIVE FOR ENTEROCOCCUS FAECALIS. INTRAOCULAR INJECTIONS WITH AN UNSPECIFIED MEDICATION WERE ADMINISTERED FOR ENDOPHTHALMITIS TREATMENT ON POSTOPERATIVE DAY 5 AND POSTOPERATIVE DAY 7 FOLLOWING THE ORIGINAL IOL PLACEMENT. AT THE TIME OF REPORTING, THE PATIENT¿S PROGNOSIS AND ONGOING TREATMENT COURSE WERE DESCRIBED AS GOOD.
Patient problems: Endophthalmitis; Hypopyon; Intraocular Pressure Increased; Visual Impairment
MAUDE report 24779916 ↗
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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