CONSTELLATION® ULTRAVIT® ENGAUGE® 8065751438Recalls & reported problems

Summary

The FDA's MAUDE database contains 237 adverse event reports that list this exact device (DI 00380657514380), received between Mar 9, 2021 and Sep 18, 2026 — classified as 237 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (194 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 237 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Failure to Cut

  A physician reported that vitrectomy probe had poor cutting during vitrectomy surgery. The surgery was completed on the same day after replacing the product with new one. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50814191 ↗
• MalfunctionJun 25, 2026Failure to Cut

  A NURSE REPORTED THAT THE VITRECTOMY PROBE COULD NOT CUT BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY HOWEVER THE REPLACEMENT DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 25619332 ↗
• MalfunctionMar 13, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT VITRECTOMY PROBE HAD POOR CUTTING PERFORMANCE 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 24598058 ↗
• MalfunctionMar 2, 2026Suction Problem

  A NURSE REPORTED THAT VITRECTOMY PROBE HAD NO ASPIRATION BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480131 ↗
• MalfunctionJan 19, 2026Suction Problem; Failure to Cut

  A NURSE REPORTED THAT THERE WAS POOR CUTTING AND POOR ASPIRATION OF VITRECTOMY PROBE 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 24107142 ↗
• MalfunctionJan 13, 2026Failure to Cut

  A NURSE REPORTED THAT THE VITRECTOMY PROBE COULD NOT CUT 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 24052162 ↗
• MalfunctionJan 13, 2026Suction Problem; Failure to Cut

  A PHYSICIAN REPORTED THAT THE SURGEON PERFORMED A RIGHT EYE MESH REMOVAL SURGERY. AFTER COMPLETING THE PATIENT'S PRELIMINARY SURGICAL PREPARATION, THE PRODUCT WAS OPENED FOR SURGERY, AND IT WAS FOUND THAT THE PROBE COULD NOT CUT AND ASPIRATE THE VITREOUS BODY NORMALLY DURING THE VITRECTOMY SURGERY. REPLACED THE PROBE WITH A NEW ONE FOR SURGERY. THE ENTIRE SURGERY WAS POSTPONED FOR TEN MINUTES, AND THERE WERE NO OTHER ABNORMALITIES. THE PATIENT RETURNED SMOOTHLY TO THE WARD AFTER COMPLETING THE SURGERY AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24051882 ↗
• MalfunctionDec 8, 2025Suction Problem; Suction Problem

  A CUSTOMER REPORTED THAT VITRECTOMY PROBE HAD STUTTERING DURING 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 23741207 ↗
• MalfunctionDec 5, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THE VITRECTOMY PROBE COULD NOT CUT BEFORE 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 23726029 ↗
• MalfunctionDec 1, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT PROBE HAD POOR ENERGY, UNABLE TO CUT BEFORE THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23689512 ↗
• MalfunctionNov 20, 2025Failure to Cut; Failure to Cut

  THE NURSE REPORTED THAT PROBE COULD NOT CUT NORMALLY DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23602964 ↗
• MalfunctionNov 20, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE PROBE COULD NOT CUT 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 23602960 ↗
• MalfunctionNov 19, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A NURSE REPORTED THAT PROBE WAS BLOCKED, IT WAS UNABLE TO CUT AND ASPIRATE THE VITREOUS BODY PROPERLY DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACEMENT WITH NEW PRODUCT. THE ENTIRE SURGERY WAS POSTPONED FOR TEN MINUTES WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23591636 ↗
• MalfunctionNov 18, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  THE NURSE REPORTED THAT PROBE WAS BLOCKED AND COULD NOT PERFORM NORMAL CUTTING OR ASPIRATION OF THE VITREOUS BODY DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACEMENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23579497 ↗
• MalfunctionNov 14, 2025Suction Problem; Suction Problem

  A NURSE REPORTED THAT THE VITRECTOMY PROBE HAD NO ASPIRATION 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 23551703 ↗
• MalfunctionNov 12, 2025Failure to Cut; Failure to Cut

  A NON-HEALTHCARE PROFESSIONAL REPORTED VIA HEALTH AUTHORITY THAT THE VITRECTOMY PROBE WAS UNABLE TO CUT PROPERLY 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 23530568 ↗
• MalfunctionNov 12, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT CUTTING PARAMETERS COULD NOT BE ADJUSTED DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23529791 ↗
• MalfunctionNov 12, 2025Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT THE PROBE HAD POOR CUTTING DURING SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY, BUT IT IS UNKNOWN HOW IT WAS PERFORMED. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23529703 ↗
• MalfunctionNov 11, 2025Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT THE PROBE COULD NOT CUT THE VITREOUS BODY DURING VITRECTOMY SURGERY FOR THE LEFT EYE. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE AND THE OPERATION PROCEEDED SMOOTHLY. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23523192 ↗
• MalfunctionNov 11, 2025Failure to Cut; Failure to Cut

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT VIA REGULATORY AUTHORITY THAT PROBE COULD NOT CUT 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 23522393 ↗
• MalfunctionNov 7, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE PROBE HAD POOR CUTTING PERFORMANCE DURING VITRECTOMY SURGERY. THE SURGERY WAS CONTINUED AND COMPLETED AFTER REPLACEMENT. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497421 ↗
• MalfunctionOct 22, 2025Suction Problem; Suction Problem

  A NURSE REPORTED THAT THE PROBE HAD NO ASPIRATION AND COULD NOT WORK DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358357 ↗
• MalfunctionOct 20, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE COULD NOT CUT 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 23337274 ↗
• MalfunctionOct 15, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THE VITRECTOMY PROBE DID NOT CUT AFTER STARTING 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 23276628 ↗
• MalfunctionSep 19, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THE PROBE HAD POOR CUTTING BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094312 ↗