Bausch + Lomb BL5114Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00757770057542), received between Feb 28, 2017 and Aug 13, 2025 — classified as 3 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Particulates” (19 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2025Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY IN THE UNITED KINGDOM REPORTED THAT DURING PREPARATION FOR THE PROCEDURE, THERE WAS CONTINUOUS RUNNING OF EXCESS QUANTITY OF IRRIGATION FLUID. THIS ALSO OCCURRED DURING THE PROCEDURE. THE PATIENT HAD IRIS TRAUMA AND A POSTERIOR CAPSULAR TEAR AND WAS SENT TO ANOTHER HEALTH CENTER FOR CATARACT INSERTION. THE EYE IS STILL UNDER REVIEW BUT IS STARTING TO HEAL.

  Patient problems: Capsular Bag Tear; Eye Injury

  MAUDE report 22800073 ↗
• MalfunctionSep 26, 2024Particulates; Particulates

  IT WAS REPORTED BY A USER FACILITY IN THE UNITED KINGDOM THAT DEBRIS WAS FOUND IN THE HANDPIECE. THE DEBRIS WAS SEEN IN THE EYE AFTER THE PHACO NEEDLE WAS INSERTED AND SCULPT WAS BEING USED. IT WAS FLUSHED OUT WITH BSS, A 1 ML SYRINGE AND CANNULA DUE TO SIZE OF DEBRIS. THE PATIENT WAS GIVEN INSTRUCTION TO ATTEND THE EMERGENCY EYE CENTER IF THEY HAD ANY ISSUES OVER THE WEEKEND AND RETURN FOR A FOLLOW UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20314985 ↗
• MalfunctionApr 30, 2024Particulates; Particulates

  IT WAS REPORTED BY A USER FACILITY IN THE UNITED KINGDOM THAT A WHITE PARTICULATE CAME OFF THE LEFT SIDE OF THE PHACO SLEEVE DURING THE PROCEDURE, AND ENTERED THE EYE. THE PARTICULATE WAS REMOVED USING FORCEPS. PRESSURES AND VISION ARE VERY GOOD, NO DISCOMFORT OR CONCERNS. THE PATIENT WAS DISCHARGED BACK TO THE COMMUNITY OPTICIAN FOR A ROUTINE POST-CATARACT ASSESSMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19216562 ↗
• MalfunctionApr 22, 2024Particulates; Particulates

  THE USER FACILITY IN THE UNITED KINGDOM REPORTED THAT A WHITE PARTICLE ENTERED THE PATIENT''S EYE DURING CATARACT SURGERY. THE PARTICLE WAS COMPLETELY REMOVED WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19160730 ↗
• MalfunctionMar 28, 2024Particulates; Particulates

  A USER FACILITY IN THE UNITED KINGDOM REPORTED THAT DURING ANTERIOR CATARACT SURGERY WITH BL5114, AT POINT OF INITIAL SCULPT WITH THE PHACO HANDPIECE AND MICS NEEDLE, THE CONSULTANT NOTICED A PIECE OF DEBRIS FLOATING IN THE EYE (LIKELY FROM THE INFUSION LINE - SUSPECTED TO BE A PIECE OF BUNG FROM THE BOTTLE). THERE WAS A SLIGHT DELAY IN OPERATION OF 2 MINUTES WHILE EXTRA VISCOELASTIC INJECTED INTO EYE AND DEBRIS REMOVED WITH FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18996173 ↗
• MalfunctionJan 2, 2024Particulates; Particulates

  A USER FACILITY IN THE UNITED KINGDOM REPORTED THAT AN A SMALL PART OF THE PURPLE TIP ENDED UP IN THE PATIENTS EYE. THE PARTICLE WAS REMOVED AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18426857 ↗
• MalfunctionDec 19, 2023Particulates; Particulates

  THE USER FACILITY IN THE UNITED KINGDOM REPORTS THAT AN UNKNOWN PARTICLE WENT INTO PATIENT''S EYE DURING SURGERY. THE SURGEON USED THE VACUUM FROM THE PHACO HANDPIECE TO REMOVE THE PARTICLE. THEY SET UP NEW TUBING AND THEY WERE ABLE TO FINISH THE CASE SUCCESSFULLY. NO PATIENT IMPACT. NO MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356008 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE USER FACILITY IN THE UNITED KINGDOM REPORTED A PATIENT DEVELOPED AN INFECTION IN THEIR EYE AND DIAGNOSED WITH ENDOPHTHALMITIS. MEDICAL INTERVENTION: POST OPERATION MEDICATION.

  Patient problems: Endophthalmitis

  MAUDE report 17838422 ↗
• MalfunctionAug 9, 2023Particulates; Particulates

  A USER FACILITY IN THE UNITED KINGDOM REPORTED A PIECE OF PLASTIC IN THE PATIENT'S EYE DURING A PROCEDURE. THE PARTICLE WAS REMOVED FROM THE PATIENT¿S EYE WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED. THE SURGERY TIME WAS INCREASED BY 0-15 MINS. THERE WAS NO IMPACT OR INJURY TO THE PATIENT, AND NO EXTRA ANESTHESIA REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17494077 ↗
• MalfunctionApr 28, 2023Particulates; Particulates

  THE USER FACILITY IN FRANCE REPORTED THAT SEVERAL MONTHS POST SURGERY, PATIENT HAD SYMPTOMS OF ABNORMAL PAIN AND BURNING. IT WAS REPORTED IT SEEMED LIKE A METAL RESIDUE WAS OBSERVED IN THE IRIS AND THERE WAS POSTERIOR CHAMBER INFLAMMATION. THE PATIENT WAS TREATED WITH LOCAL AND REGIONAL CORTICOTHERAPY. SURGERY IS PLANNED TO REMOVE THE PARTICLE HOWEVER, IT HAS NOT BEEN SCHEDULED.

  Patient problems: Eye Irritation; Eye Pain; Inflammation

  MAUDE report 16831170 ↗
• MalfunctionFeb 7, 2023Particulates; Particulates

  THE USER FACILITY IN THE UNITED KINGDOM REPORTED THAT SOME HARD PLASTIC CAME OUT OF ONE OF CARTRIDGE SETS. THE SURGEON RETRIEVED THE PLASTIC OUT OF THE PATIENT''S EYE WITHOUT CAUSING ANY DAMAGE OR IMPACT TO THE PATIENT. THE PROCEDURE WAS PROLONGED FOR ABOUT 1-2 MINUTES AND THE SURGERY WAS COMPLETED WITHOUT ADDITIONAL ANESTHESIA USAGE. THE PRODUCT NUMBER IS STILL UNKNOWN AND IS PENDING RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311776 ↗
• MalfunctionJan 24, 2023Particulates; Particulates

  IT WAS REPORTED BY THE USER FACILITY IN THE UNITED KINGDOM THAT A PIECE OF DEBRIS COME OUT OF THE PHACO PROBE INSIDE THE EYE. THE PARTICLE WAS REMOVED USING THE ASPIRATION ON THE PHACO PROBE. NO INJURY OR IMPACT TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16234777 ↗
• MalfunctionJun 8, 2022Particulates; Particulates

  THE USER FACILITY IN (B)(6) REPORTED THAT AN ELEMENT THAT LOOKS LIKE PLASTIC WAS FOUND IN THE PATIENT'S EYE DURING THE PROCEDURE. THE PARTICLE WAS REMOVED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14634320 ↗
• MalfunctionJun 8, 2022Particulates; Particulates

  THE USER FACILITY IN (B)(6) REPORTED THAT AN ELEMENT THAT LOOKS LIKE PLASTIC WAS FOUND IN THE PATIENT'S EYE DURING THE PROCEDURE. THE PARTICLE WAS REMOVED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14634280 ↗
• MalfunctionJun 8, 2022Particulates; Particulates

  THE USER FACILITY IN (B)(6) REPORTED THAT AN ELEMENT THAT LOOKS LIKE PLASTIC WAS FOUND IN THE PATIENT'S EYE DURING THE PROCEDURE. THE PARTICLE WAS REMOVED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14634264 ↗
• InjuryApr 11, 2022Particulates; Particulates

  A USER FACILITY IN (B)(6) REPORTS THAT DURING SURGERY, THE PRESENCE OF A PLASTIC ELEMENT FROM THE PHACOEMULSIFICATION HANDPIECE WAS OBSERVED BY THE OPERATOR IN THE ANTERIOR CHAMBER OF THE EYE. ASPIRATION OF THIS PLASTIC ELEMENT WAS NOT POSSIBLE WITH THE PHACOEMULSIFIER AND REQUIRED MECHANICAL REMOVAL. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14077633 ↗
• MalfunctionFeb 1, 2022Particulates; Particulates

  A USER FACILITY IN THE (B)(6) REPORTS FINDING WHITE MATTER PRESENT IN THEIR EYE DURING THE PROCEDURE. IT WAS REMOVED SUCCESSFULLY. THERE NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13418912 ↗
• MalfunctionOct 29, 2021Particulates; Particulates

  A USER FACILITY IN (B)(6) REPORTED THAT DURING THE PHACO PHASE OF CATARACT REMOVAL AND PHACO, A SMALL WHITE FOREIGN BODY WAS EXPELLED INTO THE EYE FROM THE TUBING. THE SURGEON WAS ABLE TO ASPIRATE AND COLLECT THE PARTICLE. IT IS UNKNOWN IF THE FOREIGN BODY CAME FROM WITHIN THE TUBING OR THE BALANCED SALT SOLUTION (BSS) BOTTLE. THE BSS BOTTLE DETAILS ARE NOT AVAILABLE. IT WAS DISCARDED BY STAFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12720643 ↗
• MalfunctionMay 25, 2021Particulates; Particulates

  THE USER FACILITY IN THE (B)(6) REPORTED A BLACK PARTICLE APPEARED IN THE PATIENT'S EYE DURING THE SCULPTING PHASE. THE PARTICLE WAS REMOVED AND THE SURGERY WAS PROLONGED FOR 10 MINUTES. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11879717 ↗
• MalfunctionDec 15, 2017Particulates; Particulates

  A REPORT FROM A USER FACILITY IN THE (B)(4) STATED THAT DURING SEGMENT REMOVAL, THE SURGEON FOUND IN THE ANTERIOR CHAMBER OF THE EYE, A WHITE PRESUMABLY PLASTIC PARTICLE OF APPROXIMATELY 1 MM SIZE. THE PARTICLE WAS REMOVED SUCCESSFULLY WITHOUT ANY PATIENT'S IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7120891 ↗
• MalfunctionAug 30, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DURING PHACO THERE WERE WHITE PARTICLES PRESENT. THE SURGEON REMOVED THE PARTICLE FROM THE EYE WITH A FORCEPS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6831467 ↗
• MalfunctionAug 30, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DURING PHACO THERE WERE WHITE PARTICLES PRESENT. THE SURGEON REMOVED THE PARTICLE FROM THE EYE WITH A FORCEPS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6831305 ↗
• MalfunctionAug 30, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DURING PHACO THERE WERE WHITE PARTICLES PRESENT. THE SURGEON REMOVED THE PARTICLE FROM THE EYE WITH A FORCEPS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6830724 ↗
• MalfunctionMar 22, 2017Difficult to Insert; Difficult to Insert

  IMPOSSIBLE TO WORK THE SLEEVES INTO A 1.8MM INCISION. THE SLEEVES ARE TOO SMOOTH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6424233 ↗
• MalfunctionMar 22, 2017Difficult to Insert; Difficult to Insert

  IMPOSSIBLE TO WORK THE SLEEVES INTO A 1.8MM INCISION. THE SLEEVES ARE TOO SMOOTH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6424157 ↗