Constellation, Ultravit, 25+, TotalPlus, Engauge 8065751468Recalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 00380657514687), received between Mar 19, 2021 and Mar 6, 2026 — classified as 2 injuries, 127 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (67 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 129 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT VITRECTOMY PROBE COULD NOT CUT BEFORE VITRECTOMY SURGERY. IT WAS UNKNOWN HOW THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24528248 ↗
• MalfunctionJan 14, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE COULD NOT CUT BEFORE VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO REPORTED INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24065485 ↗
• MalfunctionJan 4, 2026Failure to Cut

  A NURSE REPORTED THAT VITRECTOMY PROBE HAD POOR CUTTING DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BUT REPLACEMENT DETAILS WERE UNKNOWN. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23954164 ↗
• MalfunctionDec 26, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT PROBE COULD NOT CUT DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH NEW PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23894838 ↗
• MalfunctionDec 8, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE COULD NOT CUT DURING VITRECTOMY SURGERY. THE ASPIRATION CONDITION WAS NORMAL. 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 23741202 ↗
• MalfunctionDec 3, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THE VITRECTOMY PROBE HAD POOR CUTTING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE CONDITION OF ASPIRATION WAS UNKNOWN. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23702395 ↗
• MalfunctionNov 27, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A PHYSICIAN REPORTED THAT FLUID-AIR-EXCHANGE WAS UNABLE TO PERFORM BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING WITH NEW PRODUCT. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23665365 ↗
• MalfunctionNov 12, 2025Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT THE PROBE COULD NOT CUT DURING VITRECTOMY 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 23530349 ↗
• MalfunctionSep 4, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THE PROBE WOULD NOT CUT DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22961036 ↗
• MalfunctionAug 26, 2025Suction Problem; Suction Problem

  A NURSE REPORTED THAT BLOCKAGE IN THE PROBE BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER CHANGED A NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897148 ↗
• MalfunctionAug 12, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A PHYSICIAN REPORTED THAT THE PROBE STOPPED CUTTING AND THERE WAS WEAK ASPIRATION DURING 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 22787547 ↗
• MalfunctionAug 6, 2025Infusion or Flow Problem; Infusion or Flow Problem

  A NURSE REPORTED THAT THE INFUSION TIP HAS NO WATER OUTPUT BEFORE VITRECTOMY SURGERY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22724727 ↗
• MalfunctionJun 25, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE STOPPED CUTTING AND POOR ASPIRATION DURING 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 22326284 ↗
• MalfunctionJun 16, 2025Infusion or Flow Problem; Infusion or Flow Problem

  A NURSE REPORTED THAT THE PROBE COULD NOT CUT AND HAD NO ASPIRATION, THE PROGRESS BAR REMAINS STATIONARY AT THE PART OF THE PROBE AND THERE WAS NO LIQUID FLOWING IN OR OUT OF THE TUBING DURING CATARACT/VITRECTOMY COMBINATION SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211432 ↗
• MalfunctionJun 16, 2025Failure to Cut; Suction Failure; Failure to Cut; Suction Failure

  A NURSE REPORTED THAT THE PROBE COULD NOT CUT AND HAD NO ASPIRATION, THE PROGRESS BAR REMAINS STATIONARY AT THE PART OF THE PROBE AND THERE WAS NO LIQUID FLOWING IN OR OUT OF THE TUBING DURING CATARACT/VITRECTOMY COMBINATION SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211426 ↗
• MalfunctionJun 16, 2025Failure to Cut; Failure to Cut

  THE NURSE REPORTED THAT PROBE COULD NOT CUT AND THE ASPIRATION WAS NORMAL BEFORE THE VITRECTOMY 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 22209631 ↗
• MalfunctionJun 4, 2025No Flow; No Flow

  THE PHYSICIAN REPORTED THAT UNABLE TO PERFORM GAS-LIQUID EXCHANGE BEFORE THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143991 ↗
• InjuryMay 22, 2025Break; Break

  A PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY WHILE CUTTING THE PERIPHERAL VITREOUS, THE PATIENT EXPERIENCED SEVERE DISTURBANCE AND RETINAL TRACTION. REALIZING THE ISSUE, THE SURGERY WAS IMMEDIATELY HALTED AND THE KIT WAS REPLACED. UPON INSPECTING THE VITRECTOMY CUTTER, IT WAS FOUND THAT THE TIP OF THE PROBE WAS BROKEN. THE CURRENT PATIENT CONDITION WAS UNKNOWN.

  Patient problems: Retinal Tear

  MAUDE report 22068463 ↗
• MalfunctionMay 16, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THE VITRECTOMY PROBE HAD POOR CUTTING PERFORMANCE AND ASPIRATION CONDITION WAS NORMAL BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034326 ↗
• MalfunctionMar 26, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT VITRECTOMY PROBES COULD NOT CUT BEFORE NETWORK DISCONNECTION 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 21695284 ↗
• MalfunctionMar 20, 2025Leak/Splash; Leak/Splash

  AN OTHER HEALTH CARE PROFESSIONAL REPORTED THAT CASSETTE WAS LEAKING 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 21652133 ↗
• MalfunctionMar 11, 2025Failure to Cut; Suction Failure; Failure to Cut; Suction Failure

  A NURSE REPORTED THAT VITRECTOMY PROBE HAD NO CUTTING AND NO ASPIRATION DURING CATARACT AND VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21571013 ↗
• MalfunctionFeb 13, 2025Failure to Cut; Failure to Cut

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21372278 ↗
• MalfunctionFeb 3, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE PROBE COULD NOT CUT BEFORE VITRECTOMY 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 21291807 ↗
• MalfunctionJan 8, 2025Failure to Cut; Suction Failure; Failure to Cut; Suction Failure

  A NURSE REPORTED THAT THE VIT PROBE HAD NO CUTTING AND NO ASPIRATION, AND IT WAS SUSPECTED THERE WAS AIR LEAKAGE AT THE INTERFACE BETWEEN THE LINES AND THE HANDLE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PROBE WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21100028 ↗