Bausch + Lomb BL3124SRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 20757770059618), received between Feb 12, 2024 and Mar 13, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Particulates” (12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Particulates

  THE USER FACILITY IN AUSTRALIA REPORTED THAT AFTER THE NUCLEUS HAD BEEN EXTRACTED DURING CATARACT SURGERY WITH A 2.0 TIP AND 2.4 SLEEVE, WHEN THE NURSE REMOVED THE PHACO HANDPIECE FROM THE EYE TO SWAP TO IRRIGATION/ASPIRATION, PART OF THE SLEEVE TORE OFF AND REMAINED IN THE EYE. THE PARTICLE WAS ABLE TO REMOVED AND THE PROCEDURE WAS SUCCESSFUL WITH NO IMPACT TO THE PATIENT. STAFF NOTED THE SLEEVE MAY HAVE HAD A MICRO-TEAR PRIOR TO COMMENCING SURGERY THAT WAS UNDETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24591490 ↗
• MalfunctionNov 20, 2025Particulates; Particulates

  A USER FACILITY IN SPAIN REPORTED THAT DURING THE IRRIGATION STAGE OF EYE SURGERY, THE HOLES FROM THE SLEEVE DETACHED IN THE EYE. THEY WERE REMOVED WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23603906 ↗
• MalfunctionNov 20, 2025Particulates; Particulates

  A USER FACILITY IN SPAIN REPORTED THAT DURING THE IRRIGATION STAGE OF EYE SURGERY, THE HOLES FROM THE SLEEVE DETACHED IN THE EYE. THEY WERE REMOVED WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23603905 ↗
• MalfunctionMay 14, 2025Particulates; Particulates

  A USER FACILITY REPORTED THAT DURING TWO SEPARATE CATARACT SURGERIES, PERFORMED ON THE SAME DAY, THE SURGEON FOUND A CUT FROM ONE OF THE PORTS FROM THE YELLOW SLEEVE IN THE EYE. THE SURGEON EXTRACTED PARTICLES IMMEDIATELY WHEN NOTICED. THERE WERE NO COMPLICATIONS OR DELAYS IN THE SURGERIES. ONLY ONE PARTICLE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020351 ↗
• MalfunctionMay 14, 2025Particulates; Particulates

  A USER FACILITY REPORTED THAT DURING TWO SEPARATE CATARACT SURGERIES, PERFORMED ON THE SAME DAY, THE SURGEON FOUND A CUT FROM ONE OF THE PORTS FROM THE YELLOW SLEEVE IN THE EYE. THE SURGEON EXTRACTED PARTICLES IMMEDIATELY WHEN NOTICED. THERE WERE NO COMPLICATIONS OR DELAYS IN THE SURGERIES. ONLY ONE PARTICLE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020314 ↗
• MalfunctionDec 9, 2024Particulates; Particulates

  THE USER FACILITY REPORTED THAT DURING THE PROCEDURE, A PIECE OF THE SLEEVE WAS IN THE PATIENT'S EYE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20883721 ↗
• MalfunctionDec 6, 2024Particulates; Particulates

  A USER FACILITY IN FRANCE REPORTED THAT DURING A PROCEDURE, A PIECE OF THE SLEEVE WAS IN THE PATIENT'S EYE. IT WAS REMOVED INTRAOPERATIVELY WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860523 ↗
• MalfunctionDec 4, 2024Particulates; Particulates

  THE USER FACILITY IN FRANCE REPORTED THAT DURING THE PROCEDURE, A PIECE OF THE SLEEVE WAS IN THE PATIENT 'S EYE. IT WAS REMOVED INTRAOPERATIVELY WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20847710 ↗
• MalfunctionNov 5, 2024Particulates; Particulates

  THE USER FACILITY IN SWITZERLAND REPORTED THAT DURING THE PROCEDURE, A ROUND SECTION OF THE SIDE PORT ON THE SLEEVE GOT INTO THE PATIENT'S EYE, ALTHOUGH THE SLEEVE HAD BEEN RINSED OUT BEFOREHAND. THE SECTION OF THE SLEEVE WAS REMOVED IMMEDIATELY FROM THE EYE USING THE SUCTION SYSTEM. THE PROCEDURE WAS EXTENDED BY APPROXIMATELY FIVE MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20613142 ↗
• MalfunctionNov 5, 2024Particulates; Particulates

  THE USER FACILITY IN SWITZERLAND REPORTED THAT DURING THE PROCEDURE, A ROUND SECTION OF THE SIDE PORT ON THE SLEEVE GOT INTO THE PATIENT'S EYE, ALTHOUGH THE SLEEVE HAD BEEN RINSED OUT BEFOREHAND. THE SECTION OF THE SLEEVE WAS REMOVED IMMEDIATELY FROM THE EYE USING THE SUCTION SYSTEM. THE PROCEDURE WAS EXTENDED BY APPROXIMATELY FIVE MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20612276 ↗
• MalfunctionFeb 28, 2024Particulates; Particulates

  THE USER FACILITY REPORTED THAT A SMALL CIRCULAR CUTOUT PIECE FROM THE SLEEVE'S' IRRIGATION PORT ENTERED THE PATIENT'S EYE AND THE DOCTOR WAS ABLE TO GET IT OUT. NO PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 18799406 ↗
• MalfunctionFeb 12, 2024Particulates; Particulates

  THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684505 ↗