Bausch + Lomb BL11145Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00757770524495), received between Mar 25, 2021 and Sep 4, 2026 — classified as 19 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (25 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614489 ↗
• InjuryAug 26, 2026Improper Flow or Infusion

  The user facility reported an influx of pressure. Due to high pressure when going from phaco to I/A resulted in an influx of fluid to the eye. The procedure was halted with workaround, but patient had to return to finish the surgery. No harm to patient.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 50457469 ↗
• InjuryMay 14, 2026Decrease in Pressure

  THE USER FACILITY IN THE UNITED KINGDOM REPORTED THAT DURING A CATARACT PROCEDURE, THE ANTERIOR CHAMBER WAS UNSTABLE AND WAS COLLAPSING. AN UNEXPECTED ANTERIOR VITRECTOMY WAS PERFORMED.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 25176545 ↗
• MalfunctionApr 21, 2026Power Problem

  A USER FACILITY IN CANADA REPORTS THAT THE SYSTEM SPONTANEOUSLY POWERED OFF AND REBOOTED ON ITS OWN MULTIPLE TIMES DURING THE I/A CASE. IT WAS REPORTED THERE WAS NO PATIENT IMPACT/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940443 ↗
• MalfunctionApr 13, 2026Unexpected Shutdown

  THE USER FACILITY REPORTED THE SYSTEM STOPPED WORKING MID CASE, AFTER REBOOT GOT BL.EXE ERROR. SWITCHED SYSTEM TO FINISH CASE WHICH TOOK AROUND 5-10 MINUTES. IT IS UNKNOWN IF THEY GAVE MORE ANESTHESIA THE PATIENT WAS UNDER SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24860881 ↗
• InjuryMar 17, 2026Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT DURING CATARACT SURGERY THE CASSETTE OVERFILLED. THE CUSTOMER REPLACED THE CASSETTE, AND VACUUM CHECK FAILED MESSAGES PERSISTENTLY OCCURRED. THE CUSTOMER STATED THAT IT SEEMED LIKE THE CASSETTE FILLED MUCH FASTER THAN IT SHOULD HAVE. THE LENS IN THE RIGHT EYE WAS SUCCESSFULLY IMPLANTED, HOWEVER THE SURGERY ON THE LEFT EYE COULD NOT BE STARTED. THE CASE WAS PROLONGED 1-1.5 HOURS WHILE THE CUSTOMER ATTEMPTED TO GET THE MACHINE RUNNING AND CONTACT A REPRESENTATIVE AND TECHNICAL SUPPORT. EXCESS FLUID IN THE VETERINARY PATIENT'S LEFT EYE, WHICH WILL BE MANAGED WITH MEDICATIONS UNTIL SYSTEM IS AVAILABLE FOR CORRECTIVE SURGERY. THE RIGHT EYE VISUAL, NORMOTENSIVE, INTRAOCULAR LENS IN PLACE, WITH MODERATE UVEITIS. LEFT EYE CATARACTOUS AND NONVISUAL. EXCESS FLUID IN THE LEFT EYE WAS MANAGED WITH THE FOLLOWING MEDICATIONS: NEOMYCIN POLYMYXIN DEXAMETHASONE TOPICALLY Q6H, PREDNISOLONE ACETATE 1% TOPICALLY Q6H, DORZOLAMIDE/TIMOLOL TOPICALLY Q6H, OFLOXACIN TOPICALLY Q6H, ATROPINE TOPICALLY Q12H, CYCLOSPORINE 1% TOPICALLY Q12H (CONCURRENT KERATOCONJUNCTIVITIS SICCA), OPTIXCARE EYE LUBRICANT TOPICALLY Q12H, AMOXICILLIN/CLAVULANIC ACID PO Q12H, CARPROFEN PO 12H, GABAP

  Patient problems: Corneal Ulcer

  MAUDE report 24619711 ↗
• MalfunctionMar 5, 2026Unexpected Shutdown

  A USER FACILITY IN THE UNITED KINGDOM REPORTED THAT THE SYSTEM SHUT DOWN MID CASE. AFTER SOME TIME, THE SYSTEM WORKED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO SIGNIFICANT DELAY IN SURGERY, NO ADDITIONAL ANESTHESIA NEEDED AND NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519783 ↗
• InjuryJan 27, 2026Failure to Select Signal

  IT WAS REPORTED BY THE USER FACILITY THAT THE FOOT CONTROL DID NOT REFLUX WHEN COMMANDED AND CAUSED CONSTANT IRRIGATION WHICH DID NOT SWITCH OFF. THE CAPSULE TORE CAUSING AN ANTERIOR VITRECTOMY TO BE PERFORMED. THE SURGERY WAS COMPLETED, AND THE PATIENT IS FINE.

  Patient problems: Capsular Bag Tear

  MAUDE report 24188986 ↗
• InjuryDec 22, 2025Unexpected Shutdown; Unexpected Shutdown

  THE USER FACILITY IN FRANCE REPORTED THAT THE SYSTEM SHUT DOWN DURING PHACOEMULSIFICATION AND WHILE THE EYE WAS OPENED. THE PROCEDURE WAS DELAYED BY TWO HOURS AND 30 MINUTES AS A BACKUP MACHINE FROM ANOTHER HOSPITAL WAS BROUGHT IN. ADDITIONAL LOCAL ANESTHESIA WAS REQUIRED. IT WAS REPORTED THE PATIENT'S OUTCOME IS NORMAL EVOLUTION TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862866 ↗
• InjuryNov 20, 2025Increase in Suction; Increase in Suction

  A USER FACILITY IN GERMANY REPORTED THAT DURING SURGERY THERE WAS UNCONTROLLED, EXCESSIVE SUCTION WHICH LED TO A CAPSULE RUPTURE. A CUTTER WAS USED FOR AN ANTERIOR VITRECTOMY AND THE SYSTEM HAD TO BE RESTARTED AFTER CALIBRATION FAILED. THE PROCEDURE WAS EXTENDED BY HALF AN HOUR AND A SULCUS INTRAOCULAR LENS WAS SUCCESSFULLY IMPLANTED.

  Patient problems: Capsular Bag Tear

  MAUDE report 23604046 ↗
• MalfunctionNov 7, 2025Unexpected Shutdown; Unexpected Shutdown

  THE USER FACILITY REPORTED THE STELLARIS SYSTEM SCREEN GLITCHED, WENT BLACK, AND SYSTEM REBOOTED. THIS HAS HAPPENED ON MULITPLE CASES. ADDITIONAL INFORMATION FOR THE MULTIPLE CASES HAS BEEN REQUESTED BUT NOT RECEIVED. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498508 ↗
• MalfunctionNov 6, 2025Unexpected Shutdown; Unexpected Shutdown

  THE USER FACILITY REPORT THE SYSTEM SHUTDOWN AFTER MANY ERROR MESSAGES, (EX: WFC02, WFC09, EIV04, RCR04, VFM04), AFTER UNPLUGGING AND REBOOTING, THE SYSTEM WAS OK. THE FOOT PEDAL WAS CORDED DURING THIS ISSUE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23488456 ↗
• InjuryOct 28, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED BY THE USER FACILITY THAT THERE WAS AN ISSUE WITH CHAMBER STABILITY, AND THE CAPSULE WAS BROKEN DURING I/A MODE. THE CAPSULE BAG WAS SOFT ENOUGH WHERE IT WAS SUCKED INTO THE I/A HANDPIECE CAUSING THE BAG TO BREAK. A VITRECTOMY WAS PERFORMED, AND THE PATIENT IS LIKELY OK.

  Patient problems: Capsular Bag Tear

  MAUDE report 23404545 ↗
• InjuryAug 11, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  THE USER FACILITY IN AUSTRALIA REPORTED A WOUND BURN. THEY SUSPECTED THE PHACO MODULATION INTRODUCED ON THE (B)(6) WAS THE PROBLEM (VACUUM 100-460, BH 50, BIP 15, U/S POWER 30, FIXED PULSE WAVEFORM PD 600 PI 2) THE WOUND WAS CLOSED WITH 4-5 SUTURES. THE PATIENTS VISION IS FINE.

  Patient problems: Eye Burn

  MAUDE report 22778087 ↗
• MalfunctionJun 12, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down

  THE USER FACILITY REPORTED THE SCREEN WENT BLACK, LOST POWER, SYSTEM WAS REBOOTED AND THE CASE WAS FINISHED. THE SYSTEM SHUT DOWN AT THE BEGINNING OF THE PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT. SURGERY WAS NOT DELAYED AS THEY CHOSE TO DO THE SECOND PORTION OF THE SURGERY, FIRST, WHILE THE MACHINE RESTARTED. THE SPECULUM WAS IN THE EYE AND THE TECH HAD JUST HANDED THE FIRST BLADE TO THE SURGEON. NO INCISION IN THE EYE HAD BEEN MADE, YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194464 ↗
• MalfunctionMay 23, 2025Unexpected Shutdown; Unexpected Shutdown

  A USER FACILITY IN THE UNITED KINGDOM REPORTED THAT DURING SURGERY THE SYSTEM SHUTDOWN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079133 ↗
• MalfunctionMay 21, 2025Unexpected Shutdown; Unexpected Shutdown

  A USER FACILITY IN THE UNITED KINGDOM REPORTED THAT DURING SURGERY, THE SYSTEM SHUTDOWN. THERE WAS NO PATIENT IMPACT/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22065129 ↗
• MalfunctionApr 28, 2025Unexpected Shutdown; Unexpected Shutdown

  THE USER FACILITY IN UNITED KINGDOM REPORTED DURING A PROCEDURE THE SYSTEM SHUT DOWN AND HAD TO RESTART, CAUSING A 5 MINUTE DELAY. THE PROCEDURE THEN COMPLETED WITH NO ERRORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919041 ↗
• MalfunctionApr 1, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down

  THE USER FACILITY REPORTED THAT DURING SURGERY THE SCREEN FROZE, AND THE SYSTEM SHUT DOWN AND CAME BACK ON. THE SYSTEM HAD TO BE UNPLUGGED AND PLUGGED BACK IN TO CONTINUE THE CASE. THE SURGERY WAS PROLONGED FOR 5-10 MINUTES. THERE WAS NO PATIENT IMPACT OR INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21746242 ↗
• MalfunctionMar 13, 2025Unexpected Shutdown; Unexpected Shutdown

  THE USER FACILITY REPORT A SYSTEM SHUTDOWN DURING SEGMENT MODE. THE UNIT WAS POWERED BACK UP TO FINISH CASE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596249 ↗
• InjuryMar 11, 2025Product Quality Problem; Product Quality Problem

  ADDITIONAL INFORMATION RECEIVED SINCE THE INITIAL REPORT. LOCAL ANESTHESIA WAS USED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575069 ↗
• InjuryFeb 18, 2025Product Quality Problem; Product Quality Problem

  ON 27-JAN-2025, ADDITIONAL INFORMATION WAS RECEIVED WHICH CHANGED THE REPORTABILITY DECISION OF THIS EVENT ASSESSING IT AS REPORTABLE. THE USER FACILITY IN BELGIUM REPORTED A PROBLEM WITH THE FOOT CONTROL FUNCTION. THERE WAS NO INDICATION THAT THE ISSUE HAD AN ADVERSE EFFECT ON THE PATIENT. IT WAS LATER REPORTED THAT THE FOOT CONTROL FAILED TO FUNCTION PROPERLY DURING THE PROCEDURE. SEVERAL ATTEMPTS WERE MADE TO RESOLVE THE PROBLEM, BUT NONE WERE EFFECTIVE. ANOTHER DEVICE WAS BROUGHT IN TO CONTINUE THE SURGERY, HOWEVER, THE CORNEA HAD BECOME CLOUDY DUE TO THE DELAY AND IT WAS NO LONGER POSSIBLE TO OPERATE SAFELY. THE CORNEA WAS TREATED WITH MEDICATION AND THE PROCEDURE WAS COMPLETED FIVE DAYS LATER AT ANOTHER HOSPITAL AFTER THE CORNEA HAD SUFFICIENTLY CLEARED. AT A FOLLOW -UP CHECK APPROXIMATELY TWO MONTHS LATER, THE PATIENT WAS FOUND TO HAVE 9/10 VISION IN THAT EYE. THE PATIENT SUBSEQUENTLY DEVELOPED ¿IRVIN GLASS¿ OR FLUID AT THE HEIGHT OF THE CORNEA WHICH IS A KNOWN CONSEQUENCE OF SURGERY THAT TAKES PLACE WEEKS OR MONTHS AFTER OPHTHALMIC SURGERY. THE CURRENT STATUS OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: Corneal Clouding/Hazing

  MAUDE report 21395532 ↗
• MalfunctionJan 17, 2025Unexpected Shutdown; Unexpected Shutdown

  THE USER FACILITY IN THE NETHERLANDS REPORTED THAT DURING THE PROCEDURE, THE SYSTEM SHUT DOWN WITHOUT ANY MESSAGES. THE POWER CORD WAS UNPLUGGED, PLUGGED BACK IN AND THE SYSTEM WAS RESTARTED. THE PROCEDURE CONTINUED WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21181082 ↗
• MalfunctionNov 25, 2024Unexpected Shutdown; Unexpected Shutdown

  A USER FACILITY IN THE UNITED KINGDOM REPORTED THAT THE PHACO MACHINE LOST POWER WHILE BEING USED. THE SCREEN TURNED DARK AND LOST VACUUM. IT WAS UNREACTIVE EVEN WITH A HARD SHUT DOWN FOR A WHILE. THE FACILITY HAD TO WAIT A LONG TIME AND MANAGED TO FINALLY RESTART THE MACHINE. IT TOOK A LONG TIME BEFORE IT WAS FULLY ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20774681 ↗
• MalfunctionNov 25, 2024Unintended Application Program Shut Down; Unintended Application Program Shut Down

  THE USER FACILITY REPORTED THAT AFTER THE EIC WAS REPLACED WITH A NEW ONE, THE SYSTEM POWERED OFF DURING A CASE THE NEXT DAY. NO PATIENT IMPACT OR INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20770481 ↗