Bausch + Lomb SE5523WVRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20757770059694), received between Apr 10, 2023 and Jul 10, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Dull, Blunt” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Aug 8, 2018Terminated

   The back cap separates from the body of the vitrectomy cutter.

   Z-3275-2018 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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.

• MalfunctionJul 10, 2024Particulates; Particulates

  IT WAS REPORTED THAT THE SURGEON REMOVED A PARTICLE FROM THE EYE DURING A PROCEDURE. THE PARTICLE WAS NOTICED COMING DOWN THE IRRIGATION SIDE AND OUT THE IRRIGATION HOLE ON THE LEFT WHILE USING A QUAD TECHNIQUE FOR PHACOEMULSIFICATION. THE SURGEON HALTED THE PROCEDURE, REMOVED THE PHACOEMULSIFICATION TOOL, AND EXTRACTED THE PARTICLE WITH FORCEPS. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715578 ↗
• InjuryApr 11, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY IN THE UNITED KINGDOM REPORTED THAT DURING RETINAL DETACHMENT SURGERY, THREE TROCARS WERE LEAKING. THE PRESSURE WAS SET AT 30MMHG. SUTURES WERE REQUIRED AS THE WOUNDS DID NOT SEAL PROPERLY AT THE TROCAR ENTRY SIGHT. THE PROCEDURE WAS EXTENDED BY 15-20 MINUTES. THERE WAS NO FURTHER MEDICAL INTERVENTION NOR IMPACT OR CLINICAL CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093113 ↗
• InjuryApr 10, 2023Dull, Blunt; Dull, Blunt

  THE USER FACILITY IN FRANCE REPORTED THE INSTRUMENTS WERE NOT SHARP ENOUGH TO INSERT COMPLETELY. REPORTEDLY, THIS LED TO CHOROIDAL DETACHMENT INTRAOPERATIVELY. ANOTHER SATELLITE KIT (WITH SCLEROTOME AND TROCAR) WAS USED. THE PROCEDURE WAS DELAYED BY ONE HOUR AND THE PATIENT REQUIRED SEVERAL ADDITIONAL SCLEROTOMIES. THIS REPORT IS FOR THE SECOND PATIENT.

  Patient problems: Retinal Detachment

  MAUDE report 16707510 ↗
• InjuryApr 10, 2023Dull, Blunt; Dull, Blunt

  THE USER FACILITY IN FRANCE REPORTED THE INSTRUMENTS WERE NOT SHARP ENOUGH TO INSERT COMPLETELY. REPORTEDLY, THIS LED TO CHOROIDAL DETACHMENT INTRAOPERATIVELY. ANOTHER SATELLITE KIT (WITH SCLEROTOME AND TROCAR) WAS USED. THE PROCEDURE WAS DELAYED BY ONE HOUR AND THE PATIENT REQUIRED SEVERAL ADDITIONAL SCLEROTOMIES. THIS REPORT IS FOR THE FIRST PATIENT.

  Patient problems: Retinal Detachment

  MAUDE report 16707449 ↗