Bausch + Lomb SE5425WVBRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10757770059772), received between Mar 26, 2021 and Feb 3, 2026 — classified as 4 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (14 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Failure to Cut

  THE USER FACILITY REPORTED THE CUTTER WAS NOT CUTTING, YET WAS STILL ASPIRATING, DURING THE PROCEDURE. THERE WAS NO EFFECT ON THE PATIENT.

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

  MAUDE report 24248343 ↗
• MalfunctionFeb 3, 2026Failure to Cut

  THE USER FACILITY REPORTED THE CUTTER STOPPED WORKING BUT ASPIRATION CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245333 ↗
• MalfunctionFeb 3, 2026Failure to Cut

  THE USER FACILITY REPORTED THE CUTTER STOPPED WORKING BUT ASPIRATION CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245315 ↗
• MalfunctionJan 30, 2026Failure to Cut

  THE USER FACILITY REPORTED THE CUTTER WAS NOT CUTTING, YET WAS STILL ASPIRATING, DURING THE PROCEDURE. THERE WAS NO EFFECT ON THE PATIENT.

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

  MAUDE report 24225370 ↗
• MalfunctionMay 6, 2025Failure to Cut; Failure to Cut

  THE USER FACILITY REPORTED THAT DURING SURGERY THE VITRECTOMY CUTTER WAS NOT WORKING. THE CUTTER WAS STILL ASPIRATING AND CREATING BUBBLES IN THE LINE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21969581 ↗
• MalfunctionJul 16, 2024Particulates; Particulates

  A USER FACILITY REPORTED THAT A PIECE OF METAL WAS FOUND IN THE PATIENTS EYE AFTER SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750609 ↗
• MalfunctionMar 5, 2024Failure to Cut; Failure to Cut

  A USER FACILITY REPORTED THAT THE VITRECTOMY CUTTER STOPPED WORKING. THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838627 ↗
• MalfunctionFeb 22, 2024Failure to Cut; Failure to Cut

  THE USER FACILITY REPORTED THE VITRECTOMY CUTTER WAS NOT WORKING. THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18758122 ↗
• MalfunctionOct 20, 2023Mechanical Problem; Mechanical Problem

  THE USER FACILITY IN FRANCE REPORTED THAT A VITREOTOME HAD A MALFUNCTIONING GUILLOTINE. THERE WAS NO IMPACT TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17975849 ↗
• MalfunctionOct 5, 2023Failure to Cut; Failure to Cut

  THE USER FACILITY REPORTED THE CUTTER STOPPED CUTTING, BUT CONTINUED TO ASPIRATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17877162 ↗
• MalfunctionOct 5, 2023Failure to Cut; Failure to Cut

  THE USER FACILITY REPORTED THE CUTTER STOPPED CUTTING BUT CONTINUED TO ASPIRATE. THE PRODUCT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17877149 ↗
• MalfunctionJul 10, 2023Particulates; Particulates

  IT WAS REPORTED THAT DURING INSERTION OF VITRECTOR THE DOCTOR MET WITH RESISTANCE AND WHEN THE CUTTER ENTERED THE EYE A FOREIGN BODY WAS NOTICED IN THE EYE. THE PARTICLE WAS REMOVED USING FORCEPS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. SURGERY WAS EXTENDED MAYBE 30 MINUTES WHILE THE PATIENT WAS UNDER MONITORED ANESTHESIA CARE. BASED ON THE CHART NOTE, IT LOOKS LIKE SHE IS HEALING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17289040 ↗
• InjuryApr 3, 2023Decrease in Suction; Decrease in Suction

  IT WAS REPORTED BY THE USER FACILITY THAT THE CUTTER'S ASPIRATION WAS NOT WORKING. ASPIRATION STOPPED AND COMPLETE REMOVAL OF THE LENS WAS NOT POSSIBLE, THEREFORE A SECONDARY SURGERY WAS REQUIRED. THE SECOND SURGERY WENT FINE, WITH NO ISSUES REMOVING THE REMAINING LENS FRAGMENT. SURGERY WAS A SUCCESS.

  Patient problems: Insufficient Information

  MAUDE report 16664596 ↗
• InjuryFeb 21, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A USER FACILITY REPORTS PERFORMING A VITRECTOMY USING STELLARIS ELITE 25G POSTERIOR PACK DUE TO A POST-OP VITREOUS HEMORRHAGE. RIGHT AFTER SURGERY, THE PATIENT WAS STABLE WITHOUT ANY LEAKAGE/ BLEEDING, NORMAL IOP PRE-OP AND RIGHT AFTER SURGERY. NO SUTURES WERE USED. THERE WERE NO COMPLICATIONS DURING SURGERY, NO POST-OP INFLAMMATION/ INFECTION. NO POST-OP TRAUMA TO THE EYE. THE NEXT DAY IN CLINIC THE SURGEON NOTICED A PROBLEM WITH THE INTRAOCULAR PRESSURE. THE SURGEON FOUND THE PATIENT HAD POST-OP, SUB-CONJUNCTIVAL BLEEDING AROUND THE INFERO-TEMPORAL SITE, AND ACTIVE LEAKING AT THE SUP-TEMPORAL SCLEROTOMY AREA WHERE FLUID IS LEAKING THROUGH THE SUPERIOR-TEMPORAL CONJUNCTIVAL INCISION. THE IOP WAS 8). AIR-FLUID EXCHANGE WAS PERFORMED. THE LEAKS STOPPED AFTER PARTIAL AIR-FLUID EXCHANGE. THE PATIENT OUTCOME IS NORMAL INTRAOCULAR PRESSURE.

  Patient problems: Vitreous Hemorrhage

  MAUDE report 13573257 ↗
• MalfunctionFeb 9, 2022Failure to Cut; Failure to Cut

  A USER FACILITY IN (B)(6) REPORTS THAT THE CUTTER WAS NOT CUTTING THE VITREOUS MATERIAL EFFICIENTLY DURING THE PROCEDURE. ASPIRATION CONTINUED WHEN THE CUTTING PROBLEM OCCURRED. THERE WAS NO SIGNIFICANT DELAY IN SURGERY AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. CHANGING TO A NEW PACK RESOLVED THIS ISSUE. NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13500102 ↗
• MalfunctionOct 27, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE VITRECTOMY CUTTER QUIT FUNCTIONING AFTER APPROXIMATELY 5 MINUTES OF USE. THE SURGEON INDICATED THAT WHEN THEY STEPPED ON THE PEDAL THERE WAS AN AUDIBLE EXPRESSION OF AIR THAT APPEARED TO BE EMANATING FROM THE HOLE ABOVE THE CONNECTION OF THE EXTRUSION LINE TO THE VITRECTOR HANDPIECE. THE CUTTER WAS REMOVED FROM THE EYE. IT IS UNCLEAR IF THE ASPIRATION CONTINUED WHEN THE CUTTER STOPPED CUTTING AS THE DOCTOR DID NOT WANT TO REINSERT INTO THE EYE, AND IT WAS NOT TESTED FOR ASPIRATION OUTSIDE THE EYE. PATIENT CONTACT BUT NO MEDICAL INTERVENTION WAS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12705673 ↗
• MalfunctionMay 10, 2021Failure to Cut; Failure to Cut

  THE USER FACILITY IN (B)(6) REPORTED THE CUTTER DOES NOT CUT AND HAD TO BE EXCHANGED INTRAOPERATIVELY. THE PROCEDURE WAS EXTENDED BY 2 MINUTES 30 SECONDS. NO PATIENT IMPACT NOR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797716 ↗
• MalfunctionMay 7, 2021Failure to Cut; Failure to Cut

  THE USER FACILITY IN (B)(6) REPORTED THE CUTTER DID NOT CUT AND HAD TO BE EXCHANGED INTRAOPERATIVELY. IT WAS NOTICED AT THE BEGINNING OF THE PROCEDURE THE MATERIAL THAT WAS SUPPOSED TO BE ASPIRATED HAD NOT BEEN REMOVED; HOWEVER, ASPIRATION CONTINUED. THE PROCEDURE WAS EXTENDED BY 2 MINUTES 30 SECONDS AND WAS COMPLETED SUCCESSFULLY WITH NO ADDITIONAL ANESTHESIA REQUIRED. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11793519 ↗
• InjuryMay 6, 2021Decrease in Pressure; Complete Loss of Power; Decrease in Pressure; Complete Loss of Power

  THE USER FACILITY IN (B)(6) REPORTED THE SURGEON COMPLAINED OF A LACK OF ASPIRATION DURING A VITRECTOMY CASE. THE CUTTER WAS TESTED FOR ASPIRATION IN A GALLIPOT FILLED WITH WATER, AND IT SEEMED TO BE WORKING FINE. THE PROBLEM PERSISTED WHEN THE SURGEON USED IT IN THE PATIENTS EYE. THE ASPIRATION CONTINUED, HOWEVER, DUE TO LACK OF AIR PRESSURE, IT WAS NOT ENOUGH. THERE WAS NO ERROR MESSAGE ALERT ON THE STELLARIS ELITE PC. THE VITRECTOMY CUTTER WAS FIRST REPLACED TO CHECK IF IT HELPED, FOLLOWED BY THE POSTERIOR ONLY PACK, BUT THE ISSUE CONTINUED. THE SURGEON FELT THE CUTTER WAS NOT AS EFFICIENT AS USUAL AND DECIDED TO CLOSE THE EYE; ALSO, HE MAY NEED TO DO THE SURGERY WITH A 23G AT A LATER DATE. THE PATIENT DEVELOPED ENDOPHTHALMITIS AND IS IN RECOVERY. SURGICAL TIME WAS PROLONGED ABOUT 8-10 MINUTES. THERE WAS NO ADDITIONAL ANESTHESIA NEEDED. IT WAS NOTED THAT DURING THE PHACO PACK SETUP FOR THE NEXT CASE, THE MACHINE PROMPTED THAT THE AIR PRESSURE WAS LOW AND IT WAS FOUND THAT THERE WAS SOME LEAKAGE FROM THE AIR VALVE ON THE THEATRE WALL(THE MAIN SOURCE OF AIR PRESSURE TO STELLARIS ELITE PC MACHINE). THE AIR PRESSURE WAS BELOW 500 MM HG AT THAT STAGE. IT WAS FIXED, AND THE PACK SETU

  Patient problems: Endophthalmitis

  MAUDE report 11787239 ↗
• MalfunctionMar 26, 2021Break; Break

  B+L SALES REP REPORTED ON BEHALF OF THE USER FACILITY IN (B)(6) THAT THERE WAS A BREAK OF THE LIGHT PIPE JUST BELOW THE REINFORCEMENT RING. THE BREAK OCCURRED WHILE THE DEVICE WAS IN THE PATIENT'S EYE. A NEW LIGHT PIPE WAS USED TO COMPLETE SURGERY. THERE WERE NO CLINICAL CONSEQUENCES OR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11574899 ↗
• MalfunctionMar 26, 2021Failure to Cut; Failure to Cut

  THE USER FACILITY IN (B)(6) REPORTS THE VITRECTOMY CUTTER DID NOT WORK. THE STELLARIS CASSETTE WAS CHANGED. PATIENT IMPACT HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11574886 ↗
• InjuryMar 26, 2021Decrease in Pressure; Decrease in Pressure

  A USER FACILITY REPORTED THAT ONE OF THE TUBING LINES WAS KINKED ON THEIR CASSETTE, WHICH HELPED CREATE VERY LITTLE PRESSURE IN THE LINES AND THE CAPSULE. AN ''UNKINGING'' OF THE LINE WAS ATTEMPTED. THERE WAS NO INCREASE IN THE PRESSURE. THE CASSETTE HAD TO BE CHANGED ENTIRELY. DOING SO, LED TO A SIGNIFICANT DELAY DURING WHICH THE CAPSULE COLLAPSED, CAUSING THE RETINA TO DETACH. THE ORIGINAL SURGERY PLAN WAS FOR A VITRECTOMY WITH A SUTURED IOL. THE SURGEON ALSO HAD TO REPAIR THE IATROGENIC DETACHMENT. NO ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: Retinal Detachment

  MAUDE report 11574638 ↗