Bausch + Lomb BL5425WRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00757770058150), received between Jul 6, 2017 and Jul 6, 2017 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2017Break; Break

  THE USER FACILITY IN TAIWAN REPORTED PART OF THE CANNULA BROKE WHEN THE DOCTOR TRIED TO REMOVE THE TROCAR. THE DOCTOR INFERRED THE BROKEN PART MAY HAVE BEEN STUCK IN THE WALL OF THE PATIENT'S EYE, HENCE, HE TRIED TO ENLARGE THE INCISION TO FIND IT. THE DOCTOR SHEARED CONJUNCTIVA AND THE WOUND, BUT HE COULDN'T FIND THE BROKEN CANNULA FROM WOUND AND POSTERIOR CHAMBER IN END. SUTURE WAS USED TO CLOSE THE WOUND. THE CANNULA MAY STILL BE AT THE SCLERA. ADDITIONAL INFORMATION: THE DOCTOR DID NOT ARRANGE X-RAY EXAM, HE JUST USED OPHTHALMOSCOPE TO TRY TO FIND THE CANNULA. THE PRODUCT WAS NOT FOUND IN THE PATIENT'S EYE. THEY WILL KEEP THE PATIENT UNDER OBSERVATION TO SEE IF THERE IS ANY UNCOMFORTABLE COMPLAINT. HE DIDN'T THINK THE SECOND SURGERY IS NECESSARY. THE PRODUCT IS NOT AVAILABLE BECAUSE THE DOCTOR HAD THROWN IT AWAY.

  Patient problems: Eye Injury

  MAUDE report 6689732 ↗