Bausch + Lomb BL5111Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10757770057099), received between Dec 21, 2016 and Dec 11, 2024 — classified as 1 injury, 39 malfunctions.

The most frequently reported specific device problem is “Particulates” (35 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2024Particulates; Particulates

  IT WAS REPORTED BY THE USER FACILITY IN THE UNITED KINGDOM THAT A PATIENT TODAY HAD WHITE BITS FROM THE PHAKO TIP ENTER THE EYE. PICTURES WERE PROVIDED. THE PARTICLES WERE ASPIRATED INTO THE CASSETTE. NO MEDICAL INTERVENTION WAS REPORTED, AND THE OUTCOME WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20902114 ↗
• MalfunctionDec 11, 2024Particulates; Particulates

  IT WAS REPORTED BY THE USER FACILITY IN THE UNITED KINGDOM THAT A PATIENT TODAY HAD WHITE BITS FROM THE PHAKO TIP ENTER THE EYE. PICTURES WERE PROVIDED. THE PARTICLES WERE ASPIRATED INTO THE CASSETTE. NO MEDICAL INTERVENTION WAS REPORTED, AND THE OUTCOME WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901911 ↗
• MalfunctionDec 11, 2024Particulates; Particulates

  IT WAS REPORTED BY THE USER FACILITY IN THE UNITED KINGDOM THAT A PATIENT TODAY HAD WHITE BITS FROM THE PHAKO TIP ENTER THE EYE. PICTURES WERE PROVIDED. THE PARTICLES WERE ASPIRATED INTO THE CASSETTE. NO MEDICAL INTERVENTION WAS REPORTED, AND THE OUTCOME WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901609 ↗
• MalfunctionDec 5, 2024Particulates; Particulates

  IT WAS REPORTED BY THE USER FACILITY IN THE UNITED KINGDOM THAT A CASSETTE WITH TUBING GOT BLOCKED DURING THE QUADRANT REMOVAL. THERE IS A CHUNK OF SOMETHING BROWN IN THE TUBE WHICH STOPPED THE ASPIRATION. THE ISSUE WAS A PROBLEM WHEN SHE WENT FROM SCULPT TO SEGMENT AND COULDN¿T ASPIRATE. IT WAS A VERY SOFT LENS IN A YOUNGER PATIENT. THEY CHANGED THE CASSETTE, AND CASE WAS COMPLETED WITHOUT ISSUE. CONSULTANT CHANGED THE POST OP TREATMENT FOR THE PATIENT TO INCLUDE MAXITROL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20855333 ↗
• MalfunctionFeb 9, 2024Particulates; Particulates

  A USER FACILITY IN THE UNITED KINGDOM REPORTED THAT AN UNKNOWN SPECIMEN WAS FOUND IN THE ANTERIOR CHAMBER DURING PHACOEMULSIFICATION. THE SPECIMEN WAS REMOVED BY ASPIRATION AND APPEARS TO BE PLASTIC. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675195 ↗
• MalfunctionOct 26, 2023Particulates; Particulates

  IT WAS REPORTED BY A USER FACILITY IN GREECE THAT DURING THE PROCEDURE PLASTIC PARTICLES WERE OBSERVED FLOATING IN THE ANTERIOR CHAMBER OF THE PATIENTS EYE. THE PARTICLES WERE REMOVED THROUGH IRRIGATION AND ASPIRATION. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18015264 ↗
• MalfunctionOct 26, 2023Particulates; Particulates

  IT WAS REPORTED BY A USER FACILITY IN GREECE THAT DURING THE PROCEDURE PLASTIC PARTICLES WERE OBSERVED FLOATING IN THE ANTERIOR CHAMBER OF THE PATIENTS EYE. THE PARTICLES WERE REMOVED THROUGH IRRIGATION AND ASPIRATION. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18014765 ↗
• MalfunctionOct 26, 2023Particulates; Particulates

  IT WAS REPORTED BY A USER FACILITY IN GREECE THAT DURING THE PROCEDURE PLASTIC PARTICLES WERE OBSERVED FLOATING IN THE ANTERIOR CHAMBER OF THE PATIENT'S EYE. THE PARTICLES WERE REMOVED THROUGH IRRIGATION AND ASPIRATION. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18013895 ↗
• MalfunctionOct 26, 2023Particulates; Particulates

  IT WAS REPORTED BY A USER FACILITY IN GREECE THAT DURING THE PROCEDURE PLASTIC PARTICLES WERE OBSERVED FLOATING IN THE ANTERIOR CHAMBER OF THE PATIENTS EYE. THE PARTICLES WERE REMOVED THROUGH IRRIGATION AND ASPIRATION. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18013538 ↗
• MalfunctionAug 30, 2023Particulates; Particulates

  THE USER FACILITY IN THE UNITED KINGDOM REPORTED A SMALL WHITE OBJECT HAS BEEN EJECTED FROM THE PHACO MACHINE WHILST IN USE AND ENTERED THE PATIENT''S EYE, AND REMOVED WITH FORCEPS. THE PARTICLES WERE IDENTIFIED BY THE USER FACILITY AS BEING FROM THE WRENCH, AS A RESULT OF OVERTIGHTENING THE NEEDLE. THERE WAS NO PATIENT IMPACT AND NO MEDICAL TREATMENT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17651451 ↗
• MalfunctionAug 30, 2023Particulates; Particulates

  THE USER FACILITY IN THE UNITED KINGDOM REPORTED A SMALL WHITE OBJECT HAS BEEN EJECTED FROM THE PHACO MACHINE WHILST IN USE AND ENTERED THE PATIENT''S EYE, AND REMOVED WITH FORCEPS. THE PARTICLES WERE IDENTIFIED BY THE USER FACILITY AS BEING FROM THE WRENCH, AS A RESULT OF OVERTIGHTENING THE NEEDLE. THERE WAS NO PATIENT IMPACT AND NO MEDICAL TREATMENT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17651447 ↗
• MalfunctionMar 13, 2023Particulates; Particulates

  THE PARTICLE WAS REMOVED WITH IRRIGATION ASPIRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16529965 ↗
• MalfunctionAug 27, 2018Particulates; Particulates

  DURING A CATARACT SURGERY THE IRRIGATION BECAME CLOGGED. AFTER A WHILE IRRIGATION STARTED AGAIN AND A PARTICLE APPEARED IN THE ANTERIOR CHAMBER. THE PARTICLE CAME THRU THE SLEEVE. IT WAS 1.8 MM X 0.5 MM IN SIZE, TRANSPARENT, HARD AND PLASTIC IN APPEARANCE. THE PARTICLE WAS REMOVED FROM THE PATIENTS EYE WITH NO REPORTED IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7818232 ↗
• InjuryJul 18, 2018Complete Blockage; Complete Blockage

  DURING A CATARACT PROCEDURE THE IRRIGATION FLOW WAS SLOW AND ONLY DRIPPING. THE DOCTOR SUSPECTS BLOCKAGE WITHIN THE IRRIGATION SYSTEM. THE CAPSULE WAS RUPTURED AND A VITRECTOMY WAS PERFORMED.

  Patient problems: Capsular Bag Tear; Eye Injury; Vitrectomy

  MAUDE report 7700661 ↗
• MalfunctionMay 24, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE USER FACILITY REPORTED OBSERVING GLITTERY METALLIC PARTICLES IN THE INCISION. A FEW OF THE PARTICLES WERE OBSERVED ON THE IRIS IN CLOSE PROXIMITY TO THE MAIN INCISION. IN ONE CASE THE PARTICLES WERE OBSERVED ON THE CONJUNCTIVA IN THE AREA OF THE MAIN INCISION. THERE WAS NO INJURY OR IMPACT TO THE PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6587727 ↗
• MalfunctionMay 24, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AFTER THE SURGERY GLITTERY METALLIC PARTICLES ARE VISIBLE ON THE IRIS. THE EQUIPMENT SPECIALIST STATED ALL OF THE GLITTER PARTICULATES HAVE BEEN IN THE INCISION AND ONLY A FEW WERE VISIBLE ON THE IRIS DIRECTLY IN THE AREA OF THE MAIN INCISION AND ALSO JUST A VERY FEW IN ONE CASE ON THE CONJUNCTIVA IN THE AREA OF THE MAIN INCISION. NO PATIENT IMPACT OR INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6587189 ↗
• MalfunctionApr 28, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  SINCE SIX WEEKS THERE IS A "GLITTERY" RESIDUE AT THE INCISION AFTER THE PHACO PROCEDURE. THE RESIDUE CAN BE FLUSHED AWAY. NO PATIENT IMPACT/INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6529370 ↗
• MalfunctionJan 18, 2017Particulates; Particulates

  THE SURGEON HAS BEEN SEEING GLIMMERING SPECKS WHILE IRRIGATING THE EYE, AND IS NOT ABLE TO REMOVE THE PARTICLES. THEY ARE NOT SURE WHAT IS CAUSING THE GLIMMER. ADDITIONAL INFORMATION: THERE HAVE BEEN NO ADVERSE EFFECTS, BUT THE SURGEON DID CONFIRM THAT HE SEES THE ¿SHIMMER¿ INDEFINITELY POST-OP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6261650 ↗
• MalfunctionJan 17, 2017Particulates; Particulates

  THE SURGEON HAS BEEN SEEING GLIMMERING SPECKS WHILE IRRIGATING THE EYE, AND IS NOT ABLE TO REMOVE THE PARTICLES. THEY ARE NOT SURE WHAT IS CAUSING THE GLIMMER. ADDITIONAL INFORMATION: THERE HAVE BEEN NO ADVERSE EFFECTS, BUT THE SURGEON DID CONFIRM THAT HE SEES THE ¿SHIMMER¿ INDEFINITELY POST-OP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6257816 ↗
• MalfunctionJan 17, 2017Particulates; Particulates

  THE SURGEON HAS BEEN SEEING GLIMMERING SPECKS WHILE IRRIGATING THE EYE, AND IS NOT ABLE TO REMOVE THE PARTICLES. THEY ARE NOT SURE WHAT IS CAUSING THE GLIMMER. ADDITIONAL INFORMATION: THERE HAVE BEEN NO ADVERSE EFFECTS, BUT THE SURGEON DID CONFIRM THAT HE SEES THE ¿SHIMMER¿ INDEFINITELY POST-OP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6257792 ↗
• MalfunctionJan 17, 2017Particulates; Particulates

  THE SURGEON HAS BEEN SEEING GLIMMERING SPECKS WHILE IRRIGATING THE EYE, AND IS NOT ABLE TO REMOVE THE PARTICLES. THEY ARE NOT SURE WHAT IS CAUSING THE GLIMMER. ADDITIONAL INFORMATION: THERE HAVE BEEN NO ADVERSE EFFECTS, BUT THE SURGEON DID CONFIRM THAT HE SEES THE ¿SHIMMER¿ INDEFINITELY POST-OP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6257790 ↗
• MalfunctionJan 17, 2017Particulates; Particulates

  THE SURGEON HAS BEEN SEEING GLIMMERING SPECKS WHILE IRRIGATING THE EYE, AND IS NOT ABLE TO REMOVE THE PARTICLES. THEY ARE NOT SURE WHAT IS CAUSING THE GLIMMER. ADDITIONAL INFORMATION: THERE HAVE BEEN NO ADVERSE EFFECTS, BUT THE SURGEON DID CONFIRM THAT HE SEES THE ¿SHIMMER¿ INDEFINITELY POST-OP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6257788 ↗
• MalfunctionJan 17, 2017Particulates; Particulates

  THE SURGEON HAS BEEN SEEING GLIMMERING SPECKS WHILE IRRIGATING THE EYE, AND IS NOT ABLE TO REMOVE THE PARTICLES. THEY ARE NOT SURE WHAT IS CAUSING THE GLIMMER. ADDITIONAL INFORMATION: THERE HAVE BEEN NO ADVERSE EFFECTS, BUT THE SURGEON DID CONFIRM THAT HE SEES THE ¿SHIMMER¿ INDEFINITELY POST-OP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6257779 ↗
• MalfunctionJan 17, 2017Particulates; Particulates

  THE SURGEON HAS BEEN SEEING GLIMMERING SPECKS WHILE IRRIGATING THE EYE, AND IS NOT ABLE TO REMOVE THE PARTICLES. THEY ARE NOT SURE WHAT IS CAUSING THE GLIMMER. ADDITIONAL INFORMATION: THERE HAVE BEEN NO ADVERSE EFFECTS, BUT THE SURGEON DID CONFIRM THAT HE SEES THE ¿SHIMMER¿ INDEFINITELY POST-OP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6257766 ↗
• MalfunctionJan 17, 2017Particulates; Particulates

  THE SURGEON HAS BEEN SEEING GLIMMERING SPECKS WHILE IRRIGATING THE EYE, AND IS NOT ABLE TO REMOVE THE PARTICLES. THEY ARE NOT SURE WHAT IS CAUSING THE GLIMMER. ADDITIONAL INFORMATION: THERE HAVE BEEN NO ADVERSE EFFECTS, BUT THE SURGEON DID CONFIRM THAT HE SEES THE ¿SHIMMER¿ INDEFINITELY POST-OP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6257762 ↗