Bausch + Lomb BL15455Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00757770524532), received between Oct 11, 2021 and Sep 22, 2026 — classified as 15 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (24 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Unexpected Shutdown

  A user facility in the United Kingdom reported that the system switched off and back on in the middle of a procedure being performed. After restart all was okay. Surgeries continued with no further issues. Only a slight delay whilst system restarted. It was reported that there was no medical intervention/treatment required.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855735 ↗
• MalfunctionJul 9, 2026Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25761491 ↗
• MalfunctionDec 19, 2025Unexpected Shutdown; Unexpected Shutdown

  THE USER FACILITY IN GERMANY REPORTED THAT WHEN SWITCHING FROM PHACOEMULSIFICATION TO POSTERIOR SEGMENT, THE SYSTEM'S SCREEN WENT BLACK AND WOULD NOT START UP AGAIN. AFTER SOME TIME, THE SYSTEM WORKED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO SIGNIFICANT DELAY IN SURGERY AND NO ADDITIONAL ANESTHESIA NEEDED. THE PATIENT'S OUTCOME IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853122 ↗
• MalfunctionDec 18, 2025Unexpected Shutdown; Unexpected Shutdown

  THE USER FACILITY IN FRANCE REPORTED THE SYSTEM SHUT DOWN DURING SURGERY. THE SURGEON SWITCHED TO ANOTHER STELLARIS SYSTEM TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838912 ↗
• MalfunctionNov 13, 2025Unexpected Shutdown; Unexpected Shutdown

  A USER FACILITY IN FRANCE REPORTED THAT THE STELLARIS SHUT DOWN DURING USE. ANOTHER STELLARIS WAS USED TO FINISH THE SURGERY. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23548009 ↗
• MalfunctionOct 30, 2025Unexpected Shutdown; Unexpected Shutdown

  USER FACILITY IN CANADA HAD A SYSTEM SHUTDOWN DURING A CASE AND THE SYSTEM REBOOTED ON ITS OWN. THE FOOT PEDAL WAS WIRELESS, THE POWER CORD WAS NOT LOOSE AND SYSTEM WAS NOT MOVED WHEN THIS HAPPENED. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423461 ↗
• InjuryAug 13, 2025Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY IN THE UNITED KINGDOM REPORTED THAT DURING THE PROCEDURE, THE SYSTEM LOST INFUSION CREATING A SUPER CHOROIDAL HEMORRHAGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Choroidal Hemorrhage

  MAUDE report 22800179 ↗
• MalfunctionAug 12, 2025Unexpected Shutdown; Unexpected Shutdown

  THE USER FACILITY IN GERMANY REPORTED THAT DURING THE PROCEDURE, THE MACHINE DID NOT SWITCH FROM PROGRAM SEGMENT TO I/A MODE AND SUDDENLY WENT COMPLETELY BLACK AND SWITCHED OFF. THE SURGERY WAS COMPLETED WITH ANOTHER MACHINE. THE PROCEDURE WAS EXTENDED BY APPROXIMATELY 15 MINUTES. LOCAL ANESTHESIA WAS USED. THERE WAS NO PATIENT IMPACT, AND NO MEDICAL INTERVENTION OR TREATMENT WAS REQUIRED. THE PATIENT'S OUTCOME IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786618 ↗
• MalfunctionJul 10, 2025Unexpected Shutdown; Unexpected Shutdown

  THE USER FACILITY IN THE UNITED KINGDOM REPORTED THAT THE SYSTEM SHUT DOWN SUDDENLY DURING THE PROCEDURE. SURGERY WAS DELAYED AROUND 15 MINUTES TO CHANGE TO A BACK UP SYSTEM. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467382 ↗
• MalfunctionMay 21, 2025Unexpected Shutdown; Unexpected Shutdown

  THE USER FACILITY IN TAIWAN REPORTED DURING THE FIRST CATARACT SURGERY OF THE DAY, THE SYSTEM UNEXPECTEDLY SHUT DOWN. THE NURSE RESTARTED IT WITHIN APPROXIMATELY 3 TO 5 MINUTES, AND THE SURGERY WAS ABLE TO PROCEED AS PLANNED. THE SYSTEM RESUMED NORMAL OPERATION WITHOUT FURTHER ISSUES. ALL SUBSEQUENT SURGERIES WERE COMPLETED SUCCESSFULLY, AND NO PATIENTS WERE ADVERSELY AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061370 ↗
• MalfunctionApr 29, 2025Unexpected Shutdown; Unexpected Shutdown

  THE USER FACILITY IN SWITZERLAND REPORTED THAT DURING THE PROCEDURE, THERE WAS A POWER LOSS, REQUIRING THE CUSTOMER TO RESTART THE MACHINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928099 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY IN THE UNITED STATES REPORTED THAT CAPSULAR DAMAGE OCCURRED WITH FOUR PATIENTS, PERFORMANCE HESITATION, TRAMPOLINING, INFUSION FLUCTUATED ON FOUR VITRECTOMY CASES LAST WEEK. ADDITIONAL SURGERIES WERE NEEDED FOR EACH PATIENT (VITRECTOMY, ETC.). ANOTHER SYSTEM WAS USED TO CONTINUE. THIS REPORT IS FOR THE 4TH PATIENT.

  Patient problems: Capsular Bag Tear

  MAUDE report 21645209 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY IN THE UNITED STATES REPORTED THAT CAPSULAR DAMAGE OCCURRED WITH FOUR PATIENTS, PERFORMANCE HESITATION, TRAMPOLINING, INFUSION FLUCTUATED ON FOUR VITRECTOMY CASES LAST WEEK. ADDITIONAL SURGERIES WERE NEEDED FOR EACH PATIENT (VITRECTOMY, ETC.). ANOTHER SYSTEM WAS USED TO CONTINUE. THIS REPORT IS FOR THE 3RD PATIENT.

  Patient problems: Capsular Bag Tear

  MAUDE report 21645192 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY IN THE UNITED STATES REPORTED THAT CAPSULAR DAMAGE OCCURRED WITH FOUR PATIENTS, PERFORMANCE HESITATION, TRAMPOLINING, INFUSION FLUCTUATED ON FOUR VITRECTOMY CASES LAST WEEK. ADDITIONAL SURGERIES WERE NEEDED FOR EACH PATIENT. (VITRECTOMY, ETC.). ANOTHER SYSTEM WAS USED TO CONTINUE. THIS REPORT IS FOR THE 2ND PATIENT.

  Patient problems: Capsular Bag Tear

  MAUDE report 21645174 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY IN THE UNITED STATES REPORTED THAT CAPSULAR DAMAGE OCCURRED WITH FOUR PATIENTS, PERFORMANCE HESITATION, TRAMPOLINING, INFUSION FLUCTUATED ON FOUR VITRECTOMY CASES LAST WEEK. ADDITIONAL SURGERIES WERE NEEDED FOR EACH PATIENT (VITRECTOMY, ETC.). ANOTHER SYSTEM WAS USED TO CONTINUE. THIS REPORT IS FOR THE 1ST PATIENT.

  Patient problems: Capsular Bag Tear

  MAUDE report 21645154 ↗
• MalfunctionFeb 21, 2025Complete Loss of Power; Unexpected Shutdown; Complete Loss of Power; Unexpected Shutdown

  THE USER FACILITY IN SPAIN REPORTED THAT DURING THE PROCEDURE THE SYSTEM SHUTDOWN AND RESTARTED. IT WAS REPORTED THERE WAS NO PATIENT IMPACT, AND NO MEDICAL INTERVENTION/TREATMENT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21438822 ↗
• MalfunctionFeb 10, 2025Unexpected Shutdown; Unexpected Shutdown

  THE USER FACILITY REPORTED THE STELLARIS SYSTEM SHUT DOWN/BLACK SCREEN DURING CASE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343141 ↗
• MalfunctionJan 3, 2025Unexpected Shutdown; Unexpected Shutdown

  THE USER FACILITY IN FRANCE REPORTED THAT THE SYSTEM SHUTDOWN DURING PROCEDURE. IT WAS RESTARTED WITH NO FURTHER FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21069496 ↗
• MalfunctionNov 11, 2024Unexpected Shutdown; Unexpected Shutdown

  THE USER FACILITY REPORTED A SYSTEM SHUTDOWN DURING A CASE. IT WORKED AFTER REBOOTING TO FINISH THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20658101 ↗
• InjurySep 25, 2024Suction Problem; Noise, Audible; Suction Problem; Noise, Audible

  THE USER FACILITY IN THE UNITED KINGDOM REPORTS THAT THEY WERE PERFORMING A MACULAR HOLE REPAIR. THE FOOT PEDAL WAS BEING USED AND THE TROCARS WERE INSERTED. THE PHACO/VR MACHINE STARTED TO MAKE A STRANGE NOISE. IT WAS FURTHER EXPLAINED THAT THE IRRIGATION WAS WORKING BUT THE ASPIRATION WAS NOT. ALL CONNECTING TUBING WAS TIGHTENED AND THE VITRECTOMY PACKS WERE CHANGED TO NO AVAIL. SURGERY WAS ABANDONED. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300048 ↗
• MalfunctionSep 10, 2024Unexpected Shutdown; Unexpected Shutdown

  A USER FACILITY REPORTED THAT THE SYSTEM SHUTDOWN DURING PROCEDURES. THE SYSTEM WAS REBOOTED AND THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181905 ↗
• InjuryJul 22, 2024Suction Problem; Suction Problem

  THE USER FACILITY REPORTED NO VACUUM, IRRIGATION LOW IN SCULPT, AND THEN OBSERVED SMOKE. THEY SWITCHED SYSTEMS TO FINISH THE SURGERY WITH A 45 MINUTE DELAY. PATIENT IMPACT HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19799407 ↗
• InjuryJul 18, 2024Failure to Fire; Failure to Fire

  A USER FACILITY IN FRANCE REPORTED THAT DURING A RETINAL DETACHMENT SURGERY AT THE END OF THE AIR VITRECTOMY THE LASER WOULD NOT START. AS THEY COULD NOT GET THE DEVICE TO WORK THEY HAD TO PERMANENTLY INFUSE THE EYE WITH AIR. A SECOND MACHINE WAS USED TO COMPLETE THE SURGERY. SURGERY TIME WAS DOUBLED, HOWEVER NO ADDITIONAL ANESTHESIA WAS REQUIRED. AT THE PATIENTS FIRST CHECK UP THEIR RETINA WAS FLAT UNDER SILICONE AND PATIENT HAD A 5/10 ACUITY DUE TO THE CATARACT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19778899 ↗
• MalfunctionJun 12, 2024Loss of Power; Loss of Power

  THE USER FACILITY IN FRANCE REPORTED THE SYSTEM SHUT DOWN DURING THE PROCEDURE. THERE WAS INTERMITTENTLY NO VIDEO ON DISPLAY AND THE CASSETTE EJECTED FROM THE FLUID MODULE. THE SYSTEM WAS NOT RESTARTED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED BY USING A BACKUP SYSTEM. NO MEDICAL INTERVENTION OR ADDITIONAL ANESTHESIA WAS REQUIRED. THERE WAS NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19522235 ↗
• InjuryMay 23, 2024Power Problem; Power Problem

  A USER FACILITY IN AUSTRALIA REPORTS LOW LASER OUTPUT. THE SURGERY COULD NOT BE COMPLETED AND THE DELAY IS UNKNOWN AT THIS TIME. POWER NEEDED TO BE TURNED UP TO 700MW AND DURATION 200MS AND THEY WERE STILL STRUGGLING.

  Patient problems: Insufficient Information

  MAUDE report 19382349 ↗