Alcon, Centurion, Ultravit 8065752134Recalls & reported problems

Summary

The FDA's MAUDE database contains 134 adverse event reports that list this exact device (DI 00380657521340), received between Mar 18, 2021 and Sep 29, 2026 — classified as 8 injuries, 126 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (92 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 134 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Failure to Cut

  A physician reported that probe could not cut during vitrectomy surgery. The surgery was completed on the same day by changing the product. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932339 ↗
• MalfunctionSep 24, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889498 ↗
• MalfunctionMay 20, 2026Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT CUTTER CUTTING DEFECTS BEFORE THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25228084 ↗
• MalfunctionMay 19, 2026Failure to Cut

  A NURSE REPORTED THAT CUTTER OPERATION (CUTTING ISSUE) WAS NOT SMOOTH WHEN VITRECTOMY MODE WAS IN PROGRESS BEFORE VITRECTOMY SURGERY. THE ASPIRATION CONDITION OF PROBE WAS NORMAL. THE PROCEDURE WAS COMPLETED ON SAME DAY, BUT DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 25214270 ↗
• MalfunctionMay 12, 2026Suction Problem

  A NURSE REPORTED THAT CUTTER VACUUM DID NOT FUNCTION DURING VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150788 ↗
• MalfunctionMar 26, 2026Material Separation

  A PHYSICIAN REPORTED THAT ONE OF THE THREE TUBES DROPPED FROM THE UNIT IMMEDIATELY AFTER USE DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24696602 ↗
• MalfunctionJan 14, 2026Failure to Cut

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT ITEM WAS DEFECTIVE AND I DID NOT CUT AT AN UNKNOWN TIMING. THE SURGERY COMPLETION DETAILS AND PATIENT IMPACT WERE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24065270 ↗
• MalfunctionDec 24, 2025Suction Problem; Suction Problem

  A NURSE REPORTED THAT CUTTER VACUUM DID NOT FUNCTION BEFORE VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT THE PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23887771 ↗
• MalfunctionDec 22, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT NO ASPIRATION OF PROBE WAS PERFORMED DURING THE CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACED WITH THE SAME PRODUCT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23861862 ↗
• MalfunctionDec 20, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE HAD POOR CUTTING BEFORE THE CATARACT WITHOUT INTRAOCULAR LENS IMPLANT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23858792 ↗
• MalfunctionDec 16, 2025Suction Problem; Suction Problem

  A NURSE REPORTED THAT THE ASPIRATION WAS NOT WORKING BEFORE VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23814142 ↗
• MalfunctionNov 25, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE COULD NOT CUT BEFORE VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643160 ↗
• MalfunctionNov 25, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A NURSE REPORTED THAT POOR CUTTER AND VACUUM WERE OBSERVED BEFORE VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23641149 ↗
• MalfunctionNov 10, 2025Break; Ambient Noise Problem; Break; Ambient Noise Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE VITRECTOMY PROBE SUDDENLY BURST AND BROKE INTO TWO PIECES DURING THE VITRECTOMY SURGERY. THE SURGERY DETAILS WERE UNKNOWN. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION REQUESTED AND RECEIVED THAT THE WEIRD NOISE HAD COME FROM PROBE. THE SURGERY WAS COMPLETED BY REPLACING THE PROBE. THE SURGEON PROMPTLY WITHDREW BROKEN PART OF PROBE FROM THE EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507829 ↗
• MalfunctionNov 4, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT CUTTING WAS BEFORE VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23462684 ↗
• MalfunctionOct 28, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT UNABLE TO ASPIRATE DURING ANTERIOR VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23400998 ↗
• MalfunctionOct 17, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE COULD NOT BE ACTUATED AND NOT CUT VITREOUS BODY DURING CATARACT AND VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23325197 ↗
• MalfunctionSep 17, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT CUTTER WAS NOT CUTTING DURING CALIBRATION FOR CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23071582 ↗
• MalfunctionSep 17, 2025Failure to Cut; Failure to Cut

  AN OPHTHALMIC SURGEON REPORTED THAT CUTTING FAILURE OF CUTTERS OCCURRED DURING SET UP FOR A SURGERY (PROCEDURE TYPE WAS UNKNOWN). THE CONDITION OF ASPIRATION AND ACTUATION WAS UNKNOWN. IT WAS UNKNOWN WHETHER THE SURGERY WAS COMPLETED OR NOT. THERE WAS NO PATIENT CONTACT WITH SUSPECT PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070680 ↗
• MalfunctionSep 10, 2025Failure to Cut; Ambient Noise Problem; Failure to Cut; Ambient Noise Problem

  A PHYSICIAN REPORTED THAT LACK OF ROTATION AND CUT WAS SLOW. FURTHERMORE, A STRANGE SOUND WAS HEARD DURING THE CALIBRATION. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23023037 ↗
• MalfunctionSep 2, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A NURSE REPORTED THAT THE VITRECTOMY PROBE COULD NOT FUNCTION PROPERLY, NOT CUT AND NOT ASPIRATE BEFORE CATARACT SURGERY WITHOUT INTRAOCULAR LENS IMPLANT (IOL). THE PROCEDURE WAS COMPLETED ON SAME DAY BUT ACTION TAKEN WAS UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22935871 ↗
• MalfunctionAug 26, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED ACTUATION FAILURE OF THE PROBE OCCURRED DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT) AND IT WAS STOPPED TO BE USED. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22892404 ↗
• MalfunctionAug 21, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED ACTUATION FAILURE OF THE CUTTER OCCURRED DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22858464 ↗
• MalfunctionJul 30, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT PROBE COULD CUT BUT HAD NO ASPIRATION DURING CATARACT SURGERY (WITHOUT INTRAOCULAR LENS IMPLANT). THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22661394 ↗
• MalfunctionJul 29, 2025Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED THAT THE ANTERIOR VITRECTOMY PROBE WOULD NOT CUT PROPERLY WHILE TESTING BEFORE CATARACT AND VITRECTOMY COMBINATION SURGERY. THE PROBE WAS TO BE USED IN A PERIPHERAL IRIDECTOMY STEP. ANOTHER PROBE WAS OPENED FOR TESTING, AND EVERYTHING WORKED FINE. THERE WAS ONLY A DELAY OF FEW MINUTES DUE TO PROBE REPLACEMENT BUT THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22642837 ↗