Bausch + Lomb BL14455Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00757770524525), received between Dec 22, 2023 and Apr 23, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Unexpected Shutdown

  THE USER FACILITY IN CHINA REPORTED DURING PHACOEMULSIFICATION AND INTRAOCULAR LENS IMPLANTATION, THE SYSTEM EXPERIENCED A NEGATIVE PRESSURE FAILURE, TRIGGERING AN ALARM AND SYSTEM SHUTDOWN. FACILITY STAFF CONTACTED THE DISTRIBUTOR¿S ENGINEER WHO TROUBLESHOOTED THE FAULT REMOTELY, CAUSING THE PROCEDURE TO BE PAUSED FOR APPROXIMATELY 6 MINUTES. THE GAS PIPELINE WAS CHECKED AND THE CONNECTIONS WERE READJUSTED. AFTER RESTARTING THE SYSTEM, THE FAULT DISAPPEARED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO ADDITIONAL ANESTHESIA REQUIRED AND NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24964856 ↗
• InjuryAug 6, 2024Activation Failure; Activation Failure

  A USER FACILITY IN JAPAN REPORTS THAT DURING SURGERY A TEAR WAS FOUND, WHICH REQUIRED LASER TREATMENT, BUT COULD NOT BE PERFORMED. THE NEXT DAY, PHOTOCOAGULATION WAS PERFORMED USING LASER TREATMENT. THE PATIENT OUTCOME IS "GOOD".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19918244 ↗
• MalfunctionDec 22, 2023Unexpected Shutdown; Unexpected Shutdown

  A USER FACILITY IN AUSTRALIA REPORTED THAT DURING A PROCEDURE THE SYSTEM SHUT DOWN. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18388929 ↗