Bausch + Lomb BL5625Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 20757770057928), received between Jun 13, 2017 and Dec 1, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2023Failure to Cut; Failure to Cut

  THIS EVENT WAS REPORTED TO CHINA NATIONAL MEDICAL DEVICE ADVERSE EVENTS REPORTING SYSTEM BY A USER FACILITY IN CHINA. DURING THE VITRECTOMY WITH THE OPHTHALMIC TREATMENT SYSTEM, IT WAS FOUND THAT THE VITRECTOMY CUTTER DIDN''T CUT. THE MACHINE WAS IMMEDIATELY REPLACED AND THE TREATMENT CONTINUED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18247905 ↗
• MalfunctionJun 25, 2019Failure to Cut; Failure to Cut

  THE USER FACILITY IN (B)(6) REPORTED THE CUTTER WAS NOT CUTTING THE VITREOUS DURING SURGERY. THE ASPIRATION WAS CONTINUED. NO PATIENT IMPACT/INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8731742 ↗
• MalfunctionJun 25, 2019Failure to Cut; Failure to Cut

  THE USER FACILITY IN (B)(6) REPORTED THE CUTTER WAS NOT CUTTING THE VITREOUS DURING SURGERY. THE ASPIRATION WAS CONTINUED. NO PATIENT IMPACT/INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8731732 ↗
• MalfunctionAug 15, 2018Failure to Cut; Failure to Cut

  THE USER FACILITY IN (B)(6) REPORTED THE VITRECTOMY CUTTER DID NOT CUT. THE CUTTER STARTED TO WORK NORMALLY AFTER PEDALING THE FOOT PEDAL SEVERAL TIMES. THE SURGERY WAS COMPLETED WITH NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7784125 ↗
• MalfunctionAug 15, 2018Failure to Cut; Failure to Cut

  THE USER FACILITY IN (B)(6) REPORTED THE VITRECTOMY CUTTER DID NOT CUT. THE CUTTER STARTED TO WORK NORMALLY AFTER PEDALING THE FOOT PEDAL SEVERAL TIMES. THE SURGERY WAS COMPLETED WITH NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7784123 ↗
• MalfunctionAug 15, 2018Failure to Cut; Failure to Cut

  THE USER FACILITY IN (B)(6) REPORTED THE VITRECTOMY CUTTERS WOULD NOT CUT WHILE ASPIRATION CONTINUED. THE CUTTER WAS REPLACED WITH ANOTHER, AND THE SURGERY WAS COMPLETED WITH NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7784119 ↗
• MalfunctionAug 15, 2018Failure to Cut; Failure to Cut

  THE USER FACILITY IN (B)(6) REPORTED THE VITRECTOMY CUTTERS WOULD NOT CUT WHILE ASPIRATION CONTINUED. THE CUTTER WAS REPLACED WITH ANOTHER, AND THE SURGERY WAS COMPLETED WITH NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7784118 ↗
• MalfunctionApr 4, 2018Failure to Cut; Failure to Cut

  THE VITREOUS WAS CAUGHT ON THE FRONT OF THE CUTTER. NO PATIENT IMPACT. ADDITIONAL INFORMATION REGARDING THE NATURE OF THE PROBLEM HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7396638 ↗
• MalfunctionDec 15, 2017Failure to Cut; Failure to Cut

  THE USER FACILITY IN (B)(6) REPORTED A VITRECTOMY CUTTER DID NOT MOVE PROPERLY. IT DID ASPIRATE, BUT DID NOT CUT. IT WAS REPLACED WITH ANOTHER CUTTER AND SURGERY WAS COMPLETED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7121548 ↗
• MalfunctionJun 13, 2017Failure to Cut; Failure to Cut

  THE USER FACILITY IN (B)(6) REPORTED DURING SURGERY, THE INNER NEEDLE OF THE CUTTER DID NOT MOVE. AFTER PEDALING THE FOOT SWITCH SEVERAL TIMES, THE INNER NEEDLE STARTED TO MOVE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6636935 ↗
• MalfunctionJun 13, 2017Failure to Cut; Failure to Cut

  THE USER FACILITY IN (B)(6) REPORTED DURING SURGERY, THE INNER NEEDLE OF CUTTER DID NOT MOVE. THE FOOT SWITCH WAS DEPRESSED SEVERAL TIMES, THEN THE INNER NEEDLE STARTED TO MOVE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6636924 ↗
• MalfunctionJun 13, 2017Failure to Cut; Failure to Cut

  THE USER FACILITY IN (B)(6) REPORTED THE CUTTER DID NOT MOVE DURING SURGERY. IT WAS REPLACED WITH ANOTHER ONE AND THE SURGERY WAS COMPLETED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6636913 ↗