Constellation, Ultravit, 25+, TotalPlus, Engauge 8065751462Recalls & reported problems

Summary

The FDA's MAUDE database contains 220 adverse event reports that list this exact device (DI 00380657514625), received between Mar 4, 2021 and Aug 12, 2026 — classified as 1 injury, 219 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (99 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 220 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218383 ↗
• MalfunctionMar 2, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT VITRECTOMY PROBE WAS UNABLE TO CUT PROPERLY BEFORE VITRECTOMY SURGERY. THE SURGERY WAS PERFORMED AND COMPLETED ON THE SAME DAY BY REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24478918 ↗
• MalfunctionJan 20, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE COULD NOT CUT BEFORE THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BUT REPLACEMENT DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24112773 ↗
• MalfunctionDec 18, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE HAD NO CUTTING DURING 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 23837681 ↗
• MalfunctionNov 25, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT VITRECTOMY PROBE COULD NOT CUT BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE CONDITION OF ASPIRATION WAS UNKNOWN. THERE WAS NO INFORMATION ABOUT ANY IMPACT TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23642798 ↗
• MalfunctionNov 12, 2025Suction Problem; Suction Problem

  A NURSE REPORTED THAT PROBE HAD NO ASPIRATION DURING THE VITRECTOMY SURGERY. THE SURGERY PROCEEDED NORMALLY AFTER REPLACING WITH A NEW ONE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23529789 ↗
• MalfunctionOct 24, 2025Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED 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 23379529 ↗
• MalfunctionSep 19, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE HAD POOR CUTTING PERFORMANCE AND THE ASPIRATION WAS NORMAL BEFORE THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23093618 ↗
• MalfunctionSep 10, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE HAD POOR CUTTING 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 23013881 ↗
• MalfunctionSep 2, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A NURSE REPORTED THAT THE PROBE WAS UNABLE TO CUT AND ASPIRATE 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 22932752 ↗
• MalfunctionSep 2, 2025Failure to Cut; Suction Failure; Failure to Cut; Suction Failure

  A NURSE REPORTED VITRECTOR PROBE COULD NOT CUT AND ASPIRATE THE VITREOUS BODY NORMALLY, RESULTING IN THE INABILITY TO PERFORM NORMAL SURGERY 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 22931673 ↗
• MalfunctionAug 25, 2025Failure to Cut; Failure to Cut

  THE NURSE REPORTED THAT AN PROBE STOPPED CUTTING DURING 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 22883441 ↗
• MalfunctionAug 20, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT PROBE WAS NOT CUTTING 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 22853112 ↗
• MalfunctionAug 4, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A NURSE REPORTED THAT THE PROBE WAS BLOCKED, MAKING IT IMPOSSIBLE TO ASPIRATE AND CUT THE VITREOUS BODY NORMALLY BEFORE VITRECTOMY SURGERY. A NEW PRODUCT WAS REPLACED FOR SURGERY. THE PATIENT RETURNED SMOOTHLY TO THE WARD AFTER COMPLETING THE SURGERY WITH NO IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22697559 ↗
• MalfunctionJul 22, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT PROBE COULD NOT ASPIRATE NORMALLY BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW PRODUCT. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22562812 ↗
• MalfunctionJul 17, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THE PROBE COULD NOT CUT DURING VITRECTOMY SURGERY. THE ASPIRATION CONDITION WAS NORMAL. 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 22528915 ↗
• MalfunctionJul 14, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE HAD POOR CUTTING BEFORE PARS PLANA VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY RELACING WITH NEW PRODUCT. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22492172 ↗
• MalfunctionJun 27, 2025Leak/Splash; Leak/Splash

  THE REPORT RECEIVED FROM GOVERNMENT AGENCY REPORTED THAT PRODUCT WAS LEAKING FROM THE WATER ACCUMULATION AREA. AFTER INSPECTION, THE WATER ACCUMULATION AREA EXPLODED, CAUSING WATER LEAKAGE BEFORE THE SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PROCEDURE TYPE AND PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22346245 ↗
• MalfunctionJun 17, 2025Failure to Infuse; Failure to Infuse

  A PHYSICIAN REPORTED THAT COULD NOT PASS THE TEST AND THERE WAS NO POSTERIOR SEGMENT PERFUSION 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 22218816 ↗
• MalfunctionJun 6, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE HAD POOR CUTTING DURING VITRECTOMY 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 22157211 ↗
• MalfunctionJun 6, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE COULD NOT CUT NORMALLY DURING VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22157094 ↗
• MalfunctionJun 5, 2025Failure to Cut; Failure to Cut

  THE PHYSICIAN REPORTED THAT PROBE COULD NOT CUT 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 22147839 ↗
• MalfunctionJun 4, 2025Failure to Cut; Ambient Noise Problem; Failure to Cut; Ambient Noise Problem

  A PHYSICIAN REPORTED THAT THE PROBE COULD NOT CUT THE VITREOUS BODY PROPERLY AND THERE WERE OBVIOUS ABNORMAL NOISES DURING THE CUTTING PROCESS DURING VITRECTOMY SURGERY. AFTER REPLACING THE PROBE WITH A NEW ONE, THE SURGERY WAS COMPLETED NORMALLY. THE ASPIRATION WAS NORMAL. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22139677 ↗
• MalfunctionJun 3, 2025Suction Problem; Suction Problem

  A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT PROBE WAS WITHOUT PERFUSION 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 22129835 ↗
• MalfunctionMay 16, 2025Suction Failure; Suction Failure

  A NURSE REPORTED THAT TIP OF VITRECTOMY PROBE WAS BLOCKED BEFORE VITRECTOMY SURGERY. 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 22033840 ↗