Bausch + Lomb DP8230SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20757770056488), received between Jun 21, 2024 and Feb 5, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Particulates” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Break

  A USER FACILITY IN THE UNITED KINGDOM REPORTED THAT THE SURGEON FOUND A SHARP FRAGMENT OF PHACO NEEDLE COMING OUT FROM THE HANDPIECE WHEN PERFORMING PHACO DURING CATARACT SURGERY. IT WAS IDENTIFIED AS A BROKEN PART OF THE PHACO NEEDLE. THE SURGEON FILLED THE EYE CAVITY WITH EYEFILL HD AND REMOVED THE FRAGMENT CAREFULLY FROM THE EYE. NO EXTRA MEDICATIONS PRESCRIBED TO THE PATIENT APART FROM THE STANDARD DISCHARGE DROPS. SURGEON CONFIRMED THE FRAGMENT HAD BEEN REMOVED FROM THE EYE SAFELY AND THE IMPACT TO THE PATIENT WAS MINIMAL. THE PRODUCT HAS BEEN DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270059 ↗
• MalfunctionApr 21, 2025Break; Break

  THE USER FACILITY IN THE UNITED KINGDOM REPORTED THE PHACO NEEDLE BROKE IN THE PATIENT'S DURING PHACO. THE SURGEON IS A VITREORETINAL SURGEON AND REMOVED THE SHARD FAIRLY EASILY. THERE WAS NO REAL DELAY IN THEATRE OPERATING TIME. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875163 ↗
• MalfunctionMar 24, 2025Particulates; Particulates

  THE USER FACILITY IN THE UNITED KINGDOM REPORTED DURING PHACOEMULSIFICAION, A SMALL PIECE OF GREEN METAL APPEARED TO COME FROM THE HANDPIECE AND HAD TO BE RETRIEVED FROM THE PATIENT'S EYE. THE PARTICLE WAS INTACT ON REMOVAL AND THERE WAS NO HARM TO THE PATIENT. SITE HAVE COMPLETED THEIR OWN INVESTIGATION TO DETERMINE THE BELOW, "AFTER EXAMINING THE PHACO NEEDLE USED DURING THE PROCEDURE, I HAVE INVESTIGATED THE BELOW AND AS YOU CAN SEE WITH THE PICTURE (ATTACHED) ABOVE THE SMALL GREEN PIECE WHICH WENT INTO THE PATIENT¿S EYE HAS COME OF THE MICROFLOW NEEDLE. AS YOU CAN SEE THE MICROFLOW NEEDLE IS NOT FULLY INTACT. THE BASE SHOULD BE A COMPLETE CIRCLE AND AS YOU CAN SEE IT HAS SMALL BIT MISSING WHICH MATCHES THE BIT RECOVERED FROM THE PATIENT¿S EYE." PHOTOS TO BE ATTACHED TO FILE. THE TM PROVIDED THE FOLLOWING INFORMATION: NO MEDICAL INTERVENTION, NO CLINICAL CONSEQUENCES, NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21675973 ↗
• MalfunctionSep 10, 2024Particulates; Particulates

  IT WAS REPORTED BY THE USER FACILITY IN THE UNITED KINGDOM THAT WHILE USING THE PHACO HANDPIECE THE SURGEON FOUND FRAGMENTS OF METAL IN THE EYE. THEY APPEARED TO COME FROM THE HANDPIECE / PHACO TIP. NO CLINICAL CONSEQUENCES, MEDICAL INTERVENTION, OR PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182486 ↗
• MalfunctionJun 21, 2024Particulates; Particulates

  THE USER FACILITY IN THE UNITED KINGDOM REPORTED THE DOCTOR NOTICED ONE PARTICLE WHILE USING THE PROBE. THE PROCEDURE WAS STOPPED AND THE PARTICLE WAS RETRIEVED. THE SURGERY CONTINUED AND ANOTHER PARTICLE APPEARED. THE NEEDLE WAS CHANGED TO FINISH THE PROCEDURE. THEY WERE UNSURE IF THE PARTICLES WERE FROM THE PROBE/NEEDLE OR FROM THE HANDSET. THEY HAVE ALSO TAKEN THE PHACO HANDSET OUT OF USE UNTIL FURTHER NOTICE. THE HOSPITAL KEPT HANDPIECE AND PARTICLES TO BE COLLECTED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583186 ↗