Bausch + Lomb BL5115-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10757770058850), received between Jun 3, 2019 and Jan 9, 2026 — classified as 5 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Particulates” (20 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Particulates

  THE USER FACILITY IN SWITZERLAND REPORTED A PLASTIC PIECE FROM THE PERFORATED SLEEVE HOLE ENTERED PATIENT 'S EYE DURING PHACO-OPERATION. THE SURGEON REMOVED THE PIECE WITH AN ENDO-FORCEPS AND COMPLETED THE PROCEDURE WITHOUT ANY COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020685 ↗
• MalfunctionDec 19, 2025Particulates; Particulates

  USER FACILITY IN SWITZERLAND REPORTED A PLASTIC PIECE FROM THE PERFORATED SLEEVE HOLE ENTERED THE PATIENTS EYE DURING CATARACT PROCEDURE. THE SURGEON HAS BEEN ABLE TO REMOVE THIS PIECE OUT OF THE EYE. THEREFORE HEALON 5 VISCO WAS USED IN ORDER TO PROTECT THE ANTERIOR CHAMBER. PROLONGATION OF PROCEDURE: ABOUT 10-15 MIN. DURING THE FIRST REPORT THE CUSTOMER COULD NOT YET ESTIMATE IF THIS EVENT COULD HAVE CAUSED A PATIENT IMPACT (FOR EX. INJURY OF THE ENDOTHELIA). THIS WILL BE EVALUATED DURING THE NEXT APPOINTMENTS. THE YELLOW DEPOSIT WAS ASSERTED AND WILL BE PROVIDED TO B+L. THE CASSETTE HAS ALREADY BEEN DISCARDED AFTER PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851768 ↗
• MalfunctionDec 16, 2025Particulates; Particulates

  THE USER REPORTED THAT A DISC FROM THE YELLOW SILICONE PHACO SLEEVE WHICH IS NORMAL PUNCHED OUT FROM THE TIP WAS NOT FULLY REMOVED FROM THE SLEEVE AND DURING THE CASE THE YELLOW SILICONE DISC APPEARED IN THE ANTERIOR CHAMBER. WHICH REQUIRED THE SURGEON TO REMOVE WITH URATA FORCEPS. SCRUB THREW AWAY AFTER CASE. NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815624 ↗
• MalfunctionDec 20, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  THE USER FACILITY IN GERMANY REPORTED THAT THE INFUSION HOLE OF THE SLEEVE WAS INCOMPLETELY PERFORATED. DUE TO THE INFUSION-PRESSURE THE PARTIALLY PERFORATED SLEEVE MATERIAL WAS RINSED INTO THE EYE. THE SURGEON REMOVED THE SLEEVE-PARTICLE WITH VISCOELASTIC AND A FORCEPS FROM THE EYE. THERE WAS NO PATIENT IMPACT, NO SIGNIFICANT PROLONGATION OF PROCEDURE AND NO ADDITIONAL MEDICATION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20990099 ↗
• MalfunctionOct 25, 2024Particulates; Particulates

  THE USER FACILITY IN SWITZERLAND REPORTED THAT DURING PHACO, A PIECE OF THE SLEEVE WAS NOTICED IN THE EYE. THE PHACO WAS COMPLETED, THEN THE FOREIGN BODY WAS REMOVED FROM THE EYE. NO OTHER MEDICAL INTERVENTION OTHER THAN REMOVING THE PARTICLE WITHOUT ANY PROBLEMS. PATIENT OUTCOME IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 20532842 ↗
• MalfunctionSep 13, 2024Particulates; Particulates

  A USER FACILITY REPORTED THAT THE "HOLE PUNCH" ON THE PORT OF THE YELLOW SLEEVE WAS STILL BARELY CONNECTED AND CAME OFF DURING SURGERY. IT WAS SEEN ON THE SCREEN AND THE DOCTOR REMOVED IT DURING THE SEGMENT PORTION OF THE PROCEDURE WITH FORCEPS. DOCTOR BELIEVED IT TO BE A PORTION OF THE SLEEVE BECAUSE IT WAS PERFECTLY ROUND AND FOREIGN. THERE WAS NO PATIENT IMPACT/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20216027 ↗
• MalfunctionMay 14, 2024Particulates; Particulates

  THE USER FACILITY IN GERMANY REPORTED THAT A PIECE OF THE SILICON-SLEEVE ENTERED THE PATIENT''S EYES DURING THE PROCEDURE. IT WAS REPORTED THAT IT WAS BADLY PUNCHED-OUT. THE PIECE WAS REMOVED BY THE SURGEON WITHOUT ANY DIFFICULTIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19313096 ↗
• MalfunctionApr 17, 2024Particulates; Particulates

  A USER FACILITY IN GERMANY REPORTED THAT A PARTICLE OF THE SLEEVE ENTERED THE PATIENT''S EYE DURING THE PROCEDURE. THE PARTICLE WAS REMOVED FROM THE EYE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19128050 ↗
• MalfunctionMar 20, 2024Particulates; Particulates

  THE USER FACILITY IN SWITZERLAND REPORTED THAT A PIECE OF THE SLEEVE CAME LOOSE DURING THE PROCEDURE AND ENTERED THE PATIENT''S EYE. THE PIECE WAS REMOVED AND THE PROCEDURE CONTINUED WITH A NEW SLEEVE. THERE WAS NO IMPACT TO THE PATIENT AND NO FURTHER INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944940 ↗
• MalfunctionMar 15, 2024Particulates; Particulates

  A USER FACILITY IN GERMANY REPORTED THAT A PARTICLE OF THE SLEEVE ENTERED THE PATIENT'S EYE DURING THE PROCEDURE. THE PARTICLE WAS REMOVED FROM THE EYE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18911601 ↗
• MalfunctionMar 13, 2024Particulates; Particulates

  A PARTICLE OF THE SLEEVE ENTERED IN THE EYE DURING PHACO. THE PARTICLE WAS COMPLETELY REMOVED AND THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18894488 ↗
• MalfunctionFeb 27, 2024Particulates; Particulates

  ADDITIONAL INFORMATION RECEIVED SINCE THE INITIAL REPORT. IT WAS REPORTED THAT THE SLEEVES HAVE HOLES AND THE PLASTIC PIECE THAT WAS CUT REMAINED ON THE SLEEVE UNTIL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18790352 ↗
• MalfunctionFeb 12, 2024Particulates; Particulates

  THERE WERE NO PATIENT COMPLICATIONS.

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

  MAUDE report 18684527 ↗
• MalfunctionJan 8, 2024Particulates; Particulates

  THE USER FACILITY IN GERMANY REPORTED THAT THE SITE-HOLE OF THE SLEEVE WAS NOT ENTIRELY STAMPED OUT AND A LITTLE YELLOW PARTICLE FELL OFF THE SLEEVE AND ENTERED THE PATIENT ''S EYE. THE PARTICLE WAS REMOVED USING A CANNULA ASPIRATION AND REMOVED AFTER INCISION. THE SURGERY WAS FINISHED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT. THIS REPORT IS FOR THE SECOND PATIENT FROM THE SAME FACILITY. THE SURGERY WAS FINISHED SUCCESFULLY. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18462788 ↗
• MalfunctionJan 8, 2024Particulates; Particulates

  THE USER FACILITY IN GERMANY REPORTED THAT THE SITE-HOLE OF THE SLEEVE WAS NOT ENTIRELY STAMPED OUT AND A LITTLE YELLOW PARTICLE FELL OFF THE SLEEVE AND ENTERED THE PATIENT ''S EYE. THE PARTICLE WAS REMOVED USING A CANNULA ASPIRATION AND REMOVED AFTER INCISION. THE SURGERY WAS FINISHED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT. THIS REPORT IS FOR THE FIRST PATIENT FROM THE SAME FACILITY. THE SURGERY WAS FINISHED SUCCESSFULLY. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18462760 ↗
• InjuryJan 3, 2024Particulates; Particulates

  THE USER FACILITY IN SWITZERLAND REPORTED THAT DURING PHACO, THE TIP INJECTED PARTICLES THAT LOOKED LIKE "PLASTIC SPAGHETTIS" INTO THE PATIENT'S EYE. THE SLEEVE WAS CHANGED AND THE ISSUE STILL OCCURRED. THE CASSETTE WAS THEN CHANGED AND THE ISSUE RESOLVED. THE PARTICLES WERE REMOVED WITH END GRIPPING PINCETTE. MOST OF THE PARTICLES WERE REMOVED HOWEVER SOME VERY SMALL PARTICLES REMAINED IN THE EYE. THE PROCEDURE WAS EXTENDED BY APPROXIMATELY 15 MINUTES WITH NO ADDITIONAL ANESTHESIA. THE PATIENT WAS OKAY AFTER THE PROCEDURE HOWEVER ON DAY ONE POST OP, THE PATIENT HAD CORNEAL EDEMA WITH NO PAIN. FOLLOW UP POST OPERATIVE 5 DAY RESULTS EVERYTHING WAS FINE WITH THE PATIENT.

  Patient problems: Corneal Edema

  MAUDE report 18434821 ↗
• MalfunctionNov 16, 2023Particulates; Particulates

  THE USER FACILITY IN SWITZERLAND REPORTED A PIECE OF PLASTIC FROM SLEEVES HOLE WAS FOUND IN THE EYE. THE PERFORATION WAS INCOMPLETE, THE PLASTIC-POINT WHICH SHOULD BE ABSENT AFTER PERFORATION WAS STILL ATTACHED TO SLEEVE (HUNG ON IT). THE DOCTOR SAW IT AND REMOVED IT. UNFORTUNATELY THERE IS NO SAMPLE/ PHOTO/ VIDEO AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18152278 ↗
• 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 17930694 ↗
• MalfunctionSep 28, 2023Particulates; Particulates

  THE USER FACILITY IN SWITZERLAND REPORTED THAT DURING CATARACT SURGERY, AFTER THE NUCLEUS HAD BEEN REMOVED, THE DOCTOR NOTICED A SMALL ROUND PIECE OF PLASTIC WAS LOOSE IN THE ANTERIOR CHAMBER OF THE EYE. THE PARTICULATE WAS IMMEDIATELY REMOVED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY MAJOR DELAY. DURING POST-OP CONTROL, THERE WERE NO PATIENT PROBLEM/INCIDENCE. THE USER FACILITY REPORTED THE PARTICULATE LOOKED TO BE THE "LID" OF ONE OF THE SLEEVE''S SIDE HOLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17838088 ↗
• InjuryJul 27, 2023Increase in Suction; Inaccurate Delivery; Infusion or Flow Problem; Increase in Suction; Inaccurate Delivery; Infusion or Flow Problem

  THE PATIENT LAST VISUAL ACUITY WAS 1.6/10 WITH PERSISTENT IRREGULAR CORNEAL ASTIGMATISM (-5D CYLINDER).

  Patient problems: Corneal Scar; Eye Burn; Visual Impairment

  MAUDE report 17408426 ↗
• MalfunctionMay 2, 2023Particulates; Particulates

  A USER FACILITY IN SWITZERLAND REPORTS THAT AFTER A SHORT PERIOD OF PHACO USE, THE SURGEON NOTICED A 1MM LARGE, ELLIPTICAL, SILICONE-LIKE FOREIGN BODY IN THE EYE. ORIGIN UNKNOWN. THEY FOREIGN BODY WAS REMOVED FROM THE EYE AND RETAINED. THE SURGERY WAS DELAYED BY ABOUT 1 MINUTE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16857514 ↗
• InjuryApr 19, 2023Failure to Infuse; Failure to Infuse

  THE USER FACILITY IN FRANCE REPORTED THAT DURING THE PROCEDURE THE IRRIGATION WAS SUDDENLY INTERRUPTED RESULTING IN CHAMBER MOVEMENT AND DROOPING OF THE EYE. A CAPSULAR RUPTURE OCCURRED AND AN ANTERIOR VITRECTOMY WAS REQUIRED. WHEN THE VITREOTOME WAS CONNECTED TO THE PIPES, LACK OF INFUSION WAS NOTICED AGAIN. THE CASSETTE WAS CHANGED AND AGAIN NO INFUSION OCCURRED. A THIRD CASSETTE WAS USED AND THE IRRIGATION WORKED. THE SURGEON WAS ABLE TO PROCEED WITH RESOLVING THE CAPSULAR RUPTURE AND PLACEMENT OF THE IMPLANT. THIS REPORT IS FOR THE SECOND CASSETTE.

  Patient problems: Capsular Bag Tear

  MAUDE report 16771280 ↗
• InjuryApr 19, 2023Failure to Infuse; Failure to Infuse

  THE USER FACILITY IN FRANCE REPORTED THAT DURING THE PROCEDURE THE IRRIGATION WAS SUDDENLY INTERRUPTED RESULTING IN CHAMBER MOVEMENT AND DROOPING OF THE EYE. A CAPSULAR RUPTURE OCCURRED AND AN ANTERIOR VITRECTOMY WAS REQUIRED. WHEN THE VITREOTOME WAS CONNECTED TO THE PIPES, LACK OF INFUSION WAS NOTICED AGAIN. THE CASSETTE WAS CHANGED AND AGAIN NO INFUSION OCCURRED. A THIRD CASSETTE WAS USED AND THE IRRIGATION WORKED. THE SURGEON WAS ABLE TO PROCEED WITH RESOLVING THE CAPSULAR RUPTURE AND PLACEMENT OF THE IMPLANT. THIS REPORT IS FOR THE FIRST CASSETTE.

  Patient problems: Capsular Bag Tear

  MAUDE report 16771240 ↗
• MalfunctionJun 3, 2019Particulates; Particulates

  THE USER FACILITY IN THE (B)(6) REPORTED A WHITE PARTICLE CAME OUT OF THE NEEDLE WHEN ENTERED IN THE EYE FOR PHACO SURGERY. THE WHITE PARTICLE WAS REMOVED FROM THE ANTERIOR CHAMBER WITH FORCEPS AND THE SURGERY WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8662405 ↗
• MalfunctionJun 3, 2019Particulates; Particulates

  THE USER FACILITY IN THE (B)(6) REPORTED A WHITE PARTICLE CAME OUT OF THE NEEDLE WHEN ENTERED IN THE EYE FOR PHACO SURGERY. THE WHITE PARTICLE WAS REMOVED FROM THE ANTERIOR CHAMBER WITH FORCEPS AND THE SURGERY WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8662403 ↗