Constellation, ULTRAVIT, EdgePlus, TotalPlus 8065752452Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00380657524525), received between Mar 2, 2021 and Jan 9, 2026 — classified as 3 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (29 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 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Suction Problem; Failure to Cut

  A PHYSICIAN REPORTED THAT POOR ASPIRATION OF CUTTER AND ACTUATION WAS UNUSUAL DURING THE SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH THE SAME PRODUCT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24020305 ↗
• MalfunctionDec 26, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT CUTTER COULD NOT BE DUE TO UNSTABLE ACTUATION DURING CATARACT AND VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH ANOTHER PRODUCT. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23895589 ↗
• MalfunctionDec 22, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A PHYSICIAN REPORTED THAT ACTUATION AND ASPIRATION PROBLEMS OF CUTTER OCCURRED DURING THE CATARACT AND VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE CUTTER. THE PRODUCT WAS CONTACTED WITH PATIENT BUT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861861 ↗
• MalfunctionDec 9, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT ACTUATION ISSUE OF CUTTER OCCURRED DURING THE SURGERY. THE PROCEDURAL TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23754313 ↗
• MalfunctionDec 5, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT ISSUE WITH ACTUATION OF CUTTER OCCURRED DURING SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. PROCEDURE TYPE WAS UNKNOWN AND THERE WAS NO INFORMATION ABOUT THE PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23726272 ↗
• MalfunctionDec 5, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT THE ASPIRATION OF PROBE WAS POOR DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23726033 ↗
• MalfunctionDec 4, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT ASPIRATION OF THE PROBE WAS POOR DURING CATARACT AND VITRECTOMY COMBINED SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY, AND IT WAS UNKNOWN HOW IT GOT COMPLETED. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23714116 ↗
• MalfunctionDec 2, 2025Failure to Cut; Ambient Noise Problem; Failure to Cut; Ambient Noise Problem

  A PHYSICIAN REPORTED THAT CUTTING FAILURE OF A PROBE OCCURRED AND A LEAKING SOUND WAS HEARD DURING CALIBRATION OF VITRECTOMY SURGERY. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE CONDITION OF ASPIRATION AND ACTUATION WAS UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23689923 ↗
• MalfunctionNov 28, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT CUTTING FAILURE OF THE PROBE OCCURRED AND THE CUTTER WAS NOT OPERATING AT ITS ORIGINAL ROTATIONAL SPEED DURING CATARACT AND VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23671397 ↗
• MalfunctionNov 24, 2025Suction Problem; Ambient Noise Problem; Suction Problem; Ambient Noise Problem

  A CUSTOMER REPORTED THAT THE CUTTER COULD NOT ASPIRATE, AND SOUND WAS DIFFERENT FROM USUAL DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED BY REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23628676 ↗
• MalfunctionNov 14, 2025Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT ASPIRATION FAILURE OF THE PROBE OCCURRED DURING CATARACT AND VITRECTOMY COMBINATION 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 23553965 ↗
• MalfunctionAug 21, 2025Suction Failure; Suction Failure

  A CUSTOMER REPORTED THAT THE VITRECTOME SUCTION FAILURE IN AN UNKNOWN TIMING OF VITRECTOMY SURGERY. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT 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 22859978 ↗
• MalfunctionJun 16, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE CUTTING FAILURE OF THE PROBE OCCURRED AND THE CUTTER WAS NOT SHARP ENOUGH DURING 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 22213426 ↗
• MalfunctionJun 16, 2025Failure to Cut; Suction Failure; Failure to Cut; Suction Failure

  THE PHYSICIAN REPORTED THAT ACTUATION, CUTTING AND ASPIRATION FAILURE OF THE CUTTER OCCURRED DURING THE CATARACT/VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22209634 ↗
• MalfunctionJun 16, 2025Leak/Splash; Leak/Splash

  A NURSE REPORTED VALVED CANNULA (TROCAR) HAD SIGNIFICANT LEAK DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT PERTAINS TO ENTRY SYSTEM INVOLVED IN REPORTED EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22209580 ↗
• MalfunctionJun 12, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT THE PROBE IN THE VITRECTOMY CASSETTE WAS BENDED AND BROKEN DURING VITRECTOMY SURGERY. THE PROCEDURE COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22192429 ↗
• MalfunctionJun 4, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A PHYSICIAN REPORTED THAT THE ACTUATION, CUTTING, AND ASPIRATION FAILURE OF A PROBE OCCURRED DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE INVOLVED EYE AND THE PATIENT IDENTIFIER ARE NOT AVAILABLE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22139405 ↗
• MalfunctionMar 25, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE VITRECTOMY CUTTER STOPPED ACTUATING DURING CATARACT AND VITRECTOMY COMBINATION SURGERY. THE CONDITION OF ASPIRATION WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21686037 ↗
• MalfunctionMar 14, 2025Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED THAT THE PROBE COULD NOT CUT DURING VITRECTOMY AND CATARACT COMBINATION SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE CONDITION OF ASPIRATION WAS NORMAL. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606984 ↗
• MalfunctionMar 6, 2025Disconnection; Failure to Cut; Ambient Noise Problem; Disconnection; Failure to Cut; Ambient Noise Problem

  A OPHTHALMIC SURGEON REPORTED THAT STRANGE NOISE OCCURRED ALONG WITH ACTUATION AND CUTTING FAILURE OF PROBE DURING CATARACT AND VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT. THIS REPORT PERTAINS TO THE PROBE INVOLVED IN THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21534949 ↗
• MalfunctionJan 20, 2025Suction Problem; Suction Problem

  A OPHTHALMIC SURGEON REPORTED THAT ASPIRATION OF PROBE DID NOT WORK DURING VITRECTOMY SURGERY. THE CONDITION OF ACTUATION AND CUTTING WAS UNKNOWN. THE SURGERY WAS SUCCESSFULLY 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 21191543 ↗
• MalfunctionJan 3, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  A CUSTOMER REPORTED THAT THE FIBER OPTIC CABLE HAS A ROUGH END BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067252 ↗
• MalfunctionDec 3, 2024Failure to Cut; Ambient Noise Problem; Failure to Cut; Ambient Noise Problem

  A PHYSICIAN REPORTED THAT A STRANGE SOUND WAS HEARD AND CUTTING FAILURE OF THE PROBE OCCURRED DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE CONDITION OF ASPIRATION AND ACTUATION WAS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PROBE WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20829519 ↗
• MalfunctionOct 18, 2024Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT THE CUTTER WAS NOT SHARP ENOUGH FROM THE BEGINNING DURING SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY AFTER REPLACING THE PRODUCT. THERE WAS NO PATIENT IMPACT. THE PROCEDURE TYPE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20480502 ↗
• MalfunctionSep 27, 2024Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT THE CUTTER COULD NOT ASPIRATE DURING CATARACT/VITRECTOMY COMBINATION SURGERY. THE CONDITION OF ACTUATION AND CUTTING WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20319716 ↗