Bausch + Lomb BL5325WVRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00757770058655), received between Sep 7, 2017 and Aug 15, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2018Failure to Cut; Failure to Cut

  THE USER FACILITY IN (B)(6) REPORTED A VITRECTOMY CUTTER DID NOT CUT WHILE ASPIRATION CONTINUED. IT WAS REPLACED WITH ANOTHER ONE AND THE SURGERY WAS COMPLETED WITH NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7785334 ↗
• MalfunctionJul 11, 2018Failure to Cut; Failure to Cut

  USER FACILITY IN (B)(6) REPORTED THAT A CUTTER DID NOT CUT WHILE ASPIRATION CONTINUED. THE CUTTER WAS REPLACED WITH A NEW ONE. SURGERY WAS COMPLETED WITH NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7679339 ↗
• MalfunctionJul 11, 2018Failure to Cut; Failure to Cut

  THE USER FACILITY IN (B)(6) REPORTED THAT A CUTTER DID NOT MOVE PROPERLY DURING SURGERY, HOWEVER, ASPIRATION CONTINUED. THE CUTTER DID NOT CUT THE VITREOUS. THE CUTTER WAS REPLACED WITH ANOTHER ONE AND SURGERY CONTINUED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7679198 ↗
• MalfunctionSep 7, 2017Failure to Cut; Failure to Cut

  THE USER FACILITY IN JAPAN REPORTED THE INNER NEEDLE OF THE CUTTER SOMETIMES WAS STUCK IN THE OPEN POSITION AND COULD NOT CUT. ASPIRATION CONTINUED WHILE THE CUTTER STOPPED. IT WAS REPLACED WITH A STAND ALONE CUTTER(BL5625). NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6849048 ↗