Bausch + Lomb SE5525WVBRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10757770059765), received between Mar 26, 2021 and Aug 14, 2026 — classified as 5 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (11 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260681 ↗
• MalfunctionJun 19, 2026Failure to Cut

  THE USER FACILITY IN ITALY REPORTED THAT THE VITRECTOME DID NOT CUT AND THE ASPIRATION CONTINUED. THE VACUUM WAS CHANGED FROM 550-640, WHICH DID NOT CHANGE ANYTHING. ANOTHER VITRECTOME WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25562425 ↗
• MalfunctionMar 17, 2026Failure to Cut

  THE USER FACILITY REPORTED THAT ABOUT 10 MINUTES INTO A VITRECTOMY CASE, THE SURGEON NOTED THE VITREOUS CUTTER WAS ASPIRATING BUT APPEARED NOT TO BE CUTTING. THERE WAS NO CHANGE IN THE SOUND OF THE CUTTER. THE CUTTER WAS REPLACED AND THE CASE WAS COMPLETED WITHOUT COMPLICATION OR NEED FOR ADDITIONAL SURGICAL MANEUVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619957 ↗
• MalfunctionMar 5, 2026Failure to Cut

  A USER FACILITY REPORTED THE VITREOUS CUTTER WAS ASPIRATING BUT APPEARED TO NOT BE CUTTING. IT WAS REPORTED THERE WAS PATIENT CONTACT, AND NO IMPACT OR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519842 ↗
• MalfunctionDec 23, 2025Failure to Cut; Failure to Cut

  THE USER FACILITY IN SPAIN REPORTED DURING A PROCEDURE THE VITRECTOMY PROBE WAS NOT CUTTING, BUT ASPIRATION CONTINUED. THE DISPOSABLE PACK WAS REPLACED TO COMPLETE THE PROCEDURE, CAUSING A FIVE MINUTE DELAY. THERE WAS NO ADDITIONAL ANESTHESIA REQUIRED AND NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878429 ↗
• MalfunctionMay 14, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED BY THE USER FACILITY IN AUSTRALIA THAT THE BLADE DIDN¿T WORK HOWEVER THE PHACO WORKED FINE. CONNECTIONS ALL CHECKED THEN A NEW PACK WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22017369 ↗
• InjuryOct 29, 2024Leak/Splash; Leak/Splash

  A USER FACILITY IN THE UNITED KINGDOM REPORTED THAT DURING AN UNKNOWN NUMBER OF EYE SURGERIES, THE TROCARS LEAK. AS A RESULT THERE IS INCREASED BUBBLES WITH VISCOELASTIC OBSCURE THE SURGEONS VIEW. THE SURGEON CONFIRMED THAT SOMETIMES THE TROCARS SLIP OUT DURING SURGERY. SUTURES WERE REQUIRED AND THE PATIENT EXPERIENCE INCREASED PAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.

  Patient problems: Eye Pain

  MAUDE report 20556135 ↗
• MalfunctionAug 26, 2024Failure to Cut; Failure to Cut

  A USER FACILITY IN JAPAN REPORTED THAT THE VITRECTOMY CUTTER DID NOT MOVE WELL AND ASPIRATION CONTINUED. THE PROCEDURE WAS COMPLETED WITH A SECOND DEVICE WITH NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20063322 ↗
• InjuryMar 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE USER FACILITY IN THE UNITED KINGDOM THAT THE INFUSION LINE WAS NOT RETAINING IN THE TROCAR AND LED TO A HEMORRHAGE. SURGERY WAS EXTENDED 15-30 MINUTES FOR ADDITIONAL TREATMENT.

  Patient problems: Hyphema

  MAUDE report 19003720 ↗
• MalfunctionMar 28, 2024Failure to Cut; Failure to Cut

  THE USER FACILITY IN JAPAN REPORTED THAT DURING A PROCEDURE THE CUTTER DID NOT MOVE WELL AND IT COULD NOT CUT. IT IS UNKNOWN WHETHER THE ASPIRATION CONTINUED OR NOT. THE CUTTER WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT'S INJURY.

  Patient problems: Insufficient Information

  MAUDE report 18995781 ↗
• MalfunctionFeb 15, 2024Failure to Cut; Failure to Cut

  THE USER FACILITY REPORTED THAT THE VITRECTOMY CUTTER BEING USED IN A COMBINED CASE FAILED. THE SURGEON COMPLAINED THERE WAS NO CUTTING ACTION AT ALL. IT WAS REPLACED WITH A NEW CUTTER AND SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT. SURGERY DELAYED APPROXIMATELY 5 MINUTES. NO PATIENT HARM REPORTED. NO OTHER DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711843 ↗
• MalfunctionDec 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A USER FACILITY IN THE UNITED KINGDOM REPORTED THAT 2 TROCARS FROM THE STELLARIS ELITE 25G PACK SEPARATED AFTER POSTOPERATIVE REMOVAL FROM THE PATIENT. ONE WAS NOTICED BY THE NURSE WHEN THE SURGEON HANDED THE TROCAR BACK AFTER REMOVAL FROM THE PATIENT AND THE OTHER WAS SEEN SEPARATING AS THE SURGEON WAS TAKING THE TROCAR OUT OF THE PATIENT EYE. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT AND NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371691 ↗
• InjuryNov 7, 2023Pumping Problem; Pumping Problem

  IT WAS REPORTED BY A USER FACILITY IN THE UNITED KINGDOM THAT DURING THE INITIAL STAGES OF VITRECTOMY THERE WAS A SIGNIFICANT LOSS OF PRESSURE AND THE EYE WAS SOFTENING DESPITE BEING AT 35MMHG. PRESSURE WAS INCREASED TO 80MMHG TO TRY AND COMPENSATE BUT THERE WAS NO CHANGES. SURGEON MANUALLY INFLATED EYE AND THE PRESSURE WAS DROPPED BACK DOWN TO 35MMHG AND THE INFUSION LINE WAS REINSERTED, THE EYE BECAME EXTREMELY HARD. PRESSURE WAS REDUCED TO 10MMHG BUT THE EYE REMAINED HARD. A SECOND PACK WAS USED AND THE EYE BECAME SOFT AGAIN. THE CASE WAS COMPLETED USING A SECOND SYSTEM FROM A DIFFERENT MANUFACTURE. THE SURGERY WAS COMPLETED WITH NO IMPACT TO THE PATIENT EXCEPT THE SURGERY WAS EXTENDED 30 MINUTES AND REQUIRED ADDITIONAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18088099 ↗
• InjuryNov 7, 2023Pumping Problem; Pumping Problem

  IT WAS REPORTED BY A USER FACILITY IN THE UNITED KINGDOM THAT DURING THE INITIAL STAGES OF VITRECTOMY THERE WAS A SIGNIFICANT LOSS OF PRESSURE AND THE EYE WAS SOFTENING DESPITE BEING AT 35MMHG. PRESSURE WAS INCREASED TO 80MMHG TO TRY AND COMPENSATE BUT THERE WAS NO CHANGES. SURGEON MANUALLY INFLATED EYE AND THE PRESSURE WAS DROPPED BACK DOWN TO 35MMHG AND THE INFUSION LINE WAS REINSERTED, THE EYE BECAME EXTREMELY HARD. PRESSURE WAS REDUCED TO 10MMHG BUT THE EYE REMAINED HARD. A SECOND PACK WAS USED AND THE EYE BECAME SOFT AGAIN. THE CASE WAS COMPLETED USING A SECOND SYSTEM FROM A DIFFERENT MANUFACTURE. THE SURGERY WAS COMPLETED WITH NO IMPACT TO THE PATIENT EXCEPT THE SURGERY WAS EXTENDED 30 MINUTES, REQUIRING ADDITIONAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18088061 ↗
• MalfunctionMar 6, 2023Failure to Cut; Failure to Cut

  THE USER FACILITY REPORTED THE VITRECTOMY CUTTER WOULD NOT CUT. THE PRODUCT WAS DISPOSED OF. THERE WAS PATIENT CONTACT, BUT THE PATIENT WAS NOT INJURED. THE INCISION WAS NOT ENLARGED, NO SUTURE WAS REQUIRED; HOWEVER, THE ASPIRATION CONTINUED WHEN THE CUTTER STOPPED CUTTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16490863 ↗
• MalfunctionJan 3, 2023Particulates; Particulates

  THE USER FACILITY IN THE NETHERLANDS REPORTED THAT DEBRIS ENTERED THE PATIENT'S EYE DURING SURGERY. THE DEBRIS WAS REMOVED WITH FORCEPS AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16088968 ↗
• MalfunctionMay 17, 2021Break; Break

  A USER FACILITY IN THE UNITED KINGDOM REPORTED THAT THE SURGEON SNAPPED A 25G LIGHT PIPE WHILE MANIPULATING THE EYE. THE SURGERY WAS COMPLETED WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11836783 ↗
• MalfunctionMar 26, 2021Failure to Cut; Failure to Cut

  THE USER FACILITY IN THE UNITED KINGDOM REPORTED THE CUTTER STOPPED CUTTING. THE SURGEON RELEASED AND REAPPLIED THE PEDAL AND THE CUTTER RESTARTED FOR A FEW SECONDS AND THEN STOP AGAIN. THIS REPEATED AS THE SURGEON CAME ON AND OFF THE PEDAL. WHEN THE CUTTER STOPPED IT CONTINUED TO ASPIRATE. THIS RESULTED IN A PROLONGED PROCEDURE TIME BETWEEN 0 AND 15 MINUTES; THE EXACT TIME WAS NOT RECORDED. NO ADDITIONAL ANESTHESIA WAS REQUIRED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575524 ↗
• InjuryMar 26, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY IN THE (B)(6) REPORTED 2 LEAKING TROCARS CAUSING HYPOTONY, LEADING TO CHOROIDAL EFFUSIONS AND A RETINAL DETACHMENT. INTRAOPERATIVELY THE PRESSURE WAS ELEVATED TO 60 MMHG. SURGERY INCREASED BY MORE THAN 30 MINUTES; NO ADDITIONAL ANESTHESIA WAS NEEDED. GAS WAS INSERTED INTO THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Intraocular Pressure Decreased; Retinal Detachment

  MAUDE report 11574685 ↗