Bausch + Lomb BL5113Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00757770057238), received between Oct 15, 2021 and Feb 2, 2026 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Particulates” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Particulates

  THE USER FACILITY IN FRANCE REPORTED THAT DURING SURGERY FOR A VERY ADVANCED AND DENSE CATARACT REQUIRING A LOT OF ULTRASOUNDS, SMALL PIECES OF THE NEEDLE'S COATING WERE RELEASED INTO THE EYE. ANOTHER NEEDLE WAS REQUESTED, AND THE SAME THING HAPPENED. THESE FRAGMENTS ARE STILL PRESENT IN THE PATIENT'S EYE, WITHOUT CAUSING ANY IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232695 ↗
• MalfunctionJan 30, 2026Particulates

  THE USER FACILITY IN FRANCE REPORTED THAT DURING SURGERY FOR A VERY ADVANCED AND DENSE CATARACT REQUIRING A LOT OF ULTRASOUND, SMALL PIECES OF THE NEEDLE'S COATING WERE RELEASED INTO THE EYE. ANOTHER NEEDLE WAS REQUESTED, AND THE SAME THING HAPPENED. THESE FRAGMENTS ARE STILL PRESENT IN THE PATIENT'S EYE, WITHOUT CAUSING ANY IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222193 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY IN FRANCE REPORTED THAT DURING SURGERY THERE WAS A LARGE AMOUNT OF BUBBLES WHICH LEAD TO DECREASED VISIBILITY AND THE CAPSULE TO BE RUPTURED. A FOLLOW UP SURGERY WAS PERFORMED BY A SECONDARY RETINA SPECIALIST WHERE THEY INSERTED THE IOL AND SURGERY WAS EXTENDED BY 30 MINUTES.

  Patient problems: Capsular Bag Tear

  MAUDE report 23656838 ↗
• MalfunctionJun 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE USER FACILITY IN ITALY THAT DURING THE SURGERY, AT THE END OF PHASE IRRIGATION/ASPIRATION, WHEN THE INSTRUMENT WAS REMOVED, THE TIP BROKE AND A PART OF IT REMAINED INSIDE THE EYE. IT WAS REMOVED WITH CARE AND WITHOUT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22336404 ↗
• InjuryOct 13, 2023Inability to Irrigate; Inability to Irrigate

  A USER FACILITY IN FRANCE REPORTED THAT THE CHAMBER COLLAPSED DURING IRRIGATION AND ASPIRATION. THE IRRIGATION STOPPED WORKING AFTER ENTERING THE EYE. THE PROCEDURE WAS DELAYED AND ULTIMATELY COMPLETED TWO DAYS LATER. THE PATIENT OUTCOME IS FINE.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 17930730 ↗
• InjuryOct 13, 2023Inability to Irrigate; Inability to Irrigate

  A USER FACILITY IN FRANCE REPORTED THAT THE CHAMBER COLLAPSED DURING IRRIGATION AND ASPIRATION. THE IRRIGATION STOPPED WORKING AFTER ENTERING THE EYE. THE PROCEDURE WAS DELAYED AND ULTIMATELY COMPLETED TWO DAYS LATER. THE PATIENT OUTCOME IS FINE.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 17930629 ↗
• MalfunctionMay 4, 2023Particulates; Particulates

  THE USER FACILITY IN SWITZERLAND REPORTED THE SURGEON NOTICED A SMALL, WHITE OR TRANSPARENT FOREIGN BODY IN THE EYE. THE FOREIGN BODY WAS REMOVED AND DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16868576 ↗
• MalfunctionMar 28, 2023Particulates; Particulates

  THE USER FACILITY IN ITALY REPORTED SOME GLITTERING MATERIAL WAS NOTICED IN THE FRONT CHAMBER OF THE EYE AT THE END OF THE PHACO PHASE. THE MATERIAL WAS REMOVED WITH IRRIGATION/ASPIRATION. AFTER THE SURGERY, THE SURGEON ANALYZED THE TIP UNDER A MICROSCOPE AND NOTICED IT WAS MISSING PIECES OF PAINT. THERE WAS NO IMPACT OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16628769 ↗
• MalfunctionMar 10, 2023Particulates; Particulates

  THE USER FACILITY IN ITALY REPORTED SOME GLITTERING MATERIAL WAS NOTICED IN THE FRONT CHAMBER OF THE EYE AT THE END OF THE PHACO PHASE. THE MATERIAL WAS REMOVED WITH IRRIGATION/ASPIRATION. AFTER THE SURGERY, THE SURGEON ANALYZED THE TIP UNDER A MICROSCOPE AND NOTICED IT WAS MISSING PIECES OF PAINT. THERE WAS NO IMPACT OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16520598 ↗
• MalfunctionOct 15, 2021Particulates; Particulates

  THE USER FACILITY IN (B)(6) REPORTED THAT UNIDENTIFIED STICK PARTICLES WITH A TEXTURE SIMILAR TO SILICON WAS OBSERVED ON THE EYE. THIS OCCURRED AT THE BEGINNING OF PHACOEMULSIFICATION SURGERY WHEN THE SURGEON STARTED INFUSING IN THE EYE BEFORE ASPIRATION. CONSEQUENTLY, THE HANDPIECE WAS CHANGED BUT THE ISSUE REOCCURRED, AND NEW PARTICLES APPEARED ON THE EYE. THE CASSETTE WAS CHANGED TO SUCCESSFULLY COMPLETE THE PROCEDURE AND PARTICLES WERE REMOVED. TIME OF BOTH SURGERIES WERE 15 MINUTES LONGER DUE TO PARTICLES AND CASSETTE REPLACEMENT. NO CLINICAL CONSEQUENCES AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12640028 ↗
• MalfunctionOct 15, 2021Particulates; Particulates

  THE USER FACILITY IN (B)(6) REPORTED THAT UNIDENTIFIED STICK PARTICLES WITH A TEXTURE SIMILAR TO SILICON WAS OBSERVED ON THE EYE. THIS OCCURRED AT THE BEGINNING OF PHACOEMULSIFICATION SURGERY WHEN THE SURGEON STARTED INFUSING IN THE EYE BEFORE ASPIRATION. CONSEQUENTLY, THE HANDPIECE WAS CHANGED BUT THE ISSUE REOCCURRED, AND NEW PARTICLES APPEARED ON THE EYE. THE CASSETTE WAS CHANGED TO SUCCESSFULLY COMPLETE THE PROCEDURE AND PARTICLES WERE REMOVED. TIME OF BOTH SURGERIES WERE 15 MINUTES LONGER DUE TO PARTICLES AND CASSETTE REPLACEMENT. NO CLINICAL CONSEQUENCES AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12639929 ↗