Bausch + Lomb BL5525WVRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00757770058631), received between Jan 25, 2017 and Aug 15, 2018 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (10 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 11 most recent of 11 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 CUTTER AND THE SURGERY WAS COMPLETED WITH NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7785327 ↗
• MalfunctionAug 15, 2018Failure to Cut; Failure to Cut

  DURING A CATARACT SURGERY THE VITRECTOMY CUTTER DID NOT CUT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7784714 ↗
• MalfunctionMay 4, 2018Failure to Cut; Failure to Cut

  THE VITRECTOMY CUTTER WAS ASPIRATING YET NOT CUTTING AT THE START OF THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7487399 ↗
• MalfunctionApr 4, 2018Failure to Cut; Failure to Cut

  THE VITREOUS WAS CAUGHT IN 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 7396668 ↗
• MalfunctionAug 25, 2017Failure to Cut; Failure to Cut

  A REPORT FROM A USER FACILITY IN THE UNITED KINGDOM STATED THAT THE CUTTER STOPPED WORKING. THE CUTTER WAS RESTARTED BUT FAILED AGAIN. THE CUTTER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6820402 ↗
• MalfunctionAug 9, 2017Failure to Cut; Failure to Cut

  A REPORT RECEIVED FROM A USER FACILITY IN THE (B)(4) STATED THAT DURING THE PROCEDURE, THE VITRECTOMY CUTTER WAS NOT CUTTING WELL AND NEEDED TO BE REPLACED. THERE WAS NO REPORT OF INJURY OR CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6777353 ↗
• MalfunctionAug 8, 2017Failure to Cut; Failure to Cut

  THE VITRECTOMY CUTTER WAS NOT CUTTING YET THE ASPIRATION CONTINUED. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6773806 ↗
• MalfunctionMay 2, 2017Kinked; Infusion or Flow Problem; Kinked; Infusion or Flow Problem

  A REPORT FROM A USER FACILITY IN THE (B)(6) STATED THAT THE GREEN IRRIGATION TUBING WAS KINKED CLOSE TO THE 3 WAY TAP, RESTRICTING THE FLOW. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6539085 ↗
• MalfunctionApr 24, 2017Failure to Cut; Failure to Cut

  DURING SURGERY THE INNER NEEDLE OF A VITRECTOMY CUTTER INTERMITTENTLY STOPPED MOVING. THE CUTTER WAS REPLACED WITH ANOTHER ONE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6515412 ↗
• MalfunctionApr 6, 2017Failure to Cut; Failure to Cut

  DURING SURGERY, DRIVE NOISE OF CUTTER BECAME STRANGE AND THE INNER NEEDLE STOPPED MOVING. THE DOCTOR PAUSED SURGERY FOR A FEW SECOND AND THEN RE-STARTED. THE CUTTER WORKED FOR A WHILE, BUT THEN IT STOPPED WORKING AGAIN. IT WAS REPLACED WITH A STAND ALONE CUTTER AND THE SURGERY WAS COMPLETED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6463742 ↗
• MalfunctionJan 25, 2017Failure to Cut; Failure to Cut

  CUSTOMER IS HAVING ISSUES WITH THE CUTTER STOPPING DURING SURGERY. A REPLACEMENT CUTTER WAS USED TO COMPLETE THE PROCEDURE. THE DATE OF EVENT IS NOT AVAILABLE, AND NO PRODUCT WILL BE RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6277522 ↗