Bausch + Lomb BL5425VRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00757770058600), received between Dec 21, 2016 and Apr 3, 2018 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2018Failure to Cut; Failure to Cut

  THE DOCTOR REPORTED THE CUTTER WAS NOT CUTTING EFFICIENTLY. THEY NOTED ¿STUTTERING¿ IN THE CUTTER. ADDITIONAL INFORMATION: THEY OPENED A NEW CUTTER TO COMPLETE THE SURGERY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7393688 ↗
• MalfunctionApr 3, 2018Failure to Cut; Failure to Cut

  THE DOCTOR REPORTED THE CUTTER WAS NOT CUTTING EFFICIENTLY. ADDITIONAL INFORMATION: THEY OPENED A NEW CUTTER TO COMPLETE THE SURGERY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Valvular Stenosis

  MAUDE report 7393481 ↗
• MalfunctionFeb 16, 2018Failure to Cut; Failure to Cut

  THE USER FACILITY REPORTED THE CUTTER WAS NOT WORKING. PATIENT CONTACT, BUT NO PATIENT INJURY. ADDITIONAL INFORMATION: THE CUTTER INTERMITTENTLY STOPPED CUTTING, BUT CONTINUED TO ASPIRATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7277912 ↗
• MalfunctionFeb 8, 2017Failure to Cut; Failure to Cut

  DURING THE PROCEDURE THE VICTRECTOR STOPPED CUTTING, BUT THE ASPIRATION CONTINUED. THEY OPENED A BACKUP PACK AND CONTINUED WITH THE SURGERY WITH NO ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6312339 ↗
• MalfunctionDec 21, 2016Failure to Cut; Failure to Cut

  THE CUTTER STOPS WORKING IN MID STREAM. THE SURGEON HAS TO LIFT UP HIS FOOT FROM THE PEDAL AND THEN PRESS IT DOWN AGAIN FOR THE CUTTER TO WORK. ADDITIONAL INFORMATION: THE CUTTER IS AT 5000CPM WHEN THIS OCCURS. THIS HAS BEEN HAPPENING INTERMITTENTLY OVER TIME, NO DATE OF EVENT. THERE HAS BEEN NO INJURY TO PATIENTS AND NO NEED FOR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6195698 ↗
• MalfunctionDec 21, 2016Failure to Cut; Failure to Cut

  THE CUTTER STOPS WORKING IN MID STREAM. THE SURGEON HAS TO LIFT UP HIS FOOT FROM THE PEDAL AND THEN PRESS IT DOWN AGAIN FOR THE CUTTER TO WORK. ADDITIONAL INFORMATION: THE CUTTER IS AT 5000CPM WHEN THIS OCCURS. THIS HAS BEEN HAPPENING INTERMITTENTLY OVER TIME, NO DATE OF EVENT. THERE HAS BEEN NO INJURY TO PATIENTS AND NO NEED FOR MEDIAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6195623 ↗
• MalfunctionDec 21, 2016Failure to Cut; Failure to Cut

  THE CUTTER STOPS WORKING IN MID STREAM. THE SURGEON HAS TO LIFT UP HIS FOOT FROM THE PEDAL AND THEN PRESS IT DOWN AGAIN FOR THE CUTTER TO WORK. ADDITIONAL INFORMATION: THE CUTTER IS AT 5000CPM WHEN THIS OCCURS. THIS HAS BEEN HAPPENING INTERMITTENTLY OVER TIME, NO DATE OF EVENT. THERE HAS BEEN NO INJURY TO PATIENTS AND NO NEED FOR MEDIAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6195554 ↗