Bausch + Lomb BL5623Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20757770057911), received between Feb 23, 2017 and Dec 21, 2023 — classified as 6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2023Failure to Cut; Failure to Cut

  THE USER FACILITY IN CHINA REPORTED THAT DURING SURGERY THE VITRECTOMY CUTTER WAS NOT CUTTING. IT IS UNKNOWN IF IT CONTINUED TO ASPIRATE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371159 ↗
• MalfunctionDec 14, 2023Failure to Cut; Failure to Cut

  THIS EVENT WAS REPORTED TO CHINA NATIONAL MEDICAL DEVICE ADVERSE EVENTS REPORTING SYSTEM BY THE USER FACILITY. THE VITRECTOMY CUTTER COULDN¿T GET UP TO SPEED DURING VITRECTOMY. IT WAS FOUND THAT THE VITRECTOMY CUTTER COULD NOT REACH THE CUTTING SPEED, AND IT WAS REPLACED WITH A NEW INSTRUMENT TO ENSURE THAT THE TREATMENT CONTINUED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18324570 ↗
• MalfunctionOct 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE (B)(6) THAT DURING A VITRECTOMY SURGERY, THE TIP FRACTURED. THE PATIENT WAS UNDER LOCAL ANESTHESIA. THE TIP WAS REPLACED WITH A NEW ONE, AND THE TIP FRACTURED AGAIN. THE SURGERY WAS PERFORMED NORMALLY, AND PROLONGED BY A FEW MINUTES. THERE WAS NO HARM TO THE PATIENT AND THE NO ADDITIONAL ANESTHESIA REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12598566 ↗
• MalfunctionOct 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE (B)(6) NATIONAL MEDICAL DEVICE ADVERSE EVENTS REPORTING SYSTEM THAT DURING A VITRECTOMY SURGERY, THE TIP FRACTURED. THE PATIENT WAS UNDER LOCAL ANESTHESIA. THE TIP WAS REPLACED WITH A NEW ONE, AND THE TIP FRACTURED AGAIN. THE SURGERY WAS PERFORMED NORMALLY, AND PROLONGED BY A FEW MINUTES. THERE WAS NO HARM TO THE PATIENT AND THE NO ADDITIONAL ANESTHESIA REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12598553 ↗
• MalfunctionJun 3, 2019Failure to Cut; Failure to Cut

  THE USER FACILITY IN (B)(6) REPORTED THE VITRECTOMY CUTTER WAS NOT CUTTING THE VITREOUS; HOWEVER, ASPIRATION CONTINUED. THERE WAS NO IMPACT OR INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8662808 ↗
• MalfunctionFeb 23, 2017Failure to Cut; Failure to Cut

  A REPORT FROM A USER FACILITY IN (B)(6) INDICATED THAT DURING A PROCEDURE THE CUTTER WAS CUTTING WITH DELAY AND THE CUTTING PERFORMANCE WAS NOT GOOD. THERE WAS NO REPORT OF INJURY OR CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6354709 ↗