Bausch + Lomb SE5523WVBRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10757770059956), received between Apr 28, 2021 and Sep 25, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2024Suction Problem; Noise, Audible; Suction Problem; Noise, Audible

  THE USER FACILITY IN THE UNITED KINGDOM REPORTS THAT THEY WERE PERFORMING A MACULAR HOLE REPAIR. THE FOOT PEDAL WAS BEING USED AND THE TROCARS WERE INSERTED. THE PHACO/VR MACHINE STARTED TO MAKE A STRANGE NOISE. IT WAS FURTHER EXPLAINED THAT THE IRRIGATION WAS WORKING BUT THE ASPIRATION WAS NOT. ALL CONNECTING TUBING WAS TIGHTENED AND THE VITRECTOMY PACKS WERE CHANGED TO NO AVAIL. SURGERY WAS ABANDONED. THERE WAS NO PATIENT IMPACT; NO MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20299968 ↗
• MalfunctionAug 8, 2024Failure to Cut; Failure to Cut

  A USER FACILITY IN THE UNITED KINGDOM REPORTED THAT THE DEVICE DID NOT CUT DURING THE VITRECTOMY PROCEDURE, HOWEVER, ASPIRATION CONTINUED. THE DEVICE WAS REPLACED AND SURGERY WAS COMPLETED WITH NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939774 ↗
• MalfunctionFeb 28, 2024Failure to Cut; Failure to Cut

  THE USER FACILITY IN ITALY REPORTED THE VITREOUS CUTTER WAS NOT WORKING AND MADE A VENT-LIKE NOISE WHEN THE DOCTOR ACTIVATED THE CUT.

  Patient problems: Insufficient Information

  MAUDE report 18799733 ↗
• InjuryApr 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY IN THE (B)(4) OBSERVED DURING SURGERY FOLLOWING THE INITIAL TROCAR INSERTION, THE EYE BECAME SOFT DUE TO THE TROCAR LEAKING. THE TROCAR APPEARED TO BE INSERTED WITH THE CORRECT TECHNIQUE. INFUSION LINE WAS CONNECTED TO RE-PRESSURIZE THE EYE AND PLACE TWO OTHER TROCARS, BUT THE TROCARS CONTINUED TO LEAK DURING THE CASE. THE PATIENT WAS NOT ADVERSELY AFFECTED, AND NO ADDITIONAL TREATMENT WAS REQUIRED. THE INFUSION PRESSURE WAS 35MMHG DURING THE OBSERVED LEAKING. THIS OCCURRED DURING A GENE THERAPY CASE WHICH SHOULD HAVE INCLUDED A DRY SAMPLE OF VITREOUS BEFORE APPLYING INFUSION, BUT THIS COULD NOT OCCUR DUE TO THE EYE BEING TOO SOFT TO INSERT A SECOND TROCAR FOR THE SAMPLE. THEREFORE, NO PATIENT IMPACT, BUT CAUSED A DEVIATION FROM A STRICT PROTOCOL. THE PATIENT WILL NOT UNDERGO AN ADDITIONAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739692 ↗