CONSTELLATION® ULTRAVIT® ENGAUGE® 8065750949Recalls & reported problems

Summary

The FDA's MAUDE database contains 203 adverse event reports that list this exact device (DI 00380657509492), received between Apr 13, 2021 and Aug 24, 2026 — classified as 1 injury, 202 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (153 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 203 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Suction Problem

  A healthcare professional reported that the probe had no suction during vitrectomy surgery. The surgery was completed on the same day after replacing the product with a new one. There was no information about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50402127 ↗
• MalfunctionJun 30, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE COULD NOT CUT BEFORE 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 25663474 ↗
• MalfunctionMar 25, 2026Failure to Cut

  A NURSE REPORTED THAT THE PROBE COULD CUT, BUT THE SPEED TURNED LOW AND COULD NOT REACH THE TARGET SPEED 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 24687503 ↗
• MalfunctionMar 25, 2026Failure to Cut

  A NURSE REPORTED THAT THE PROBE COULD CUT, BUT THE SPEED TURNED LOW AND COULD NOT REACH THE TARGET SPEED 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 24687501 ↗
• MalfunctionMar 24, 2026Failure to Cut

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24672342 ↗
• MalfunctionFeb 19, 2026Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT PROBE HAD POOR CUTTING AND ASPIRATION WAS GOOD BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24386478 ↗
• MalfunctionFeb 17, 2026Failure to Cut

  A HEALTH CARE PROFESSIONAL REPORTED THAT PROBE HAD POOR CUTTING AND THE ASPIRATION WAS NORMAL BEFORE VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED ON SAME DAY. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24362244 ↗
• MalfunctionFeb 17, 2026Failure to Cut

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE ASPIRATION OF PROBE WAS NORMAL, AND THE PROBE HAD POOR CUTTING BEFORE THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BUT UNKNOWN HOW IT WAS COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24362106 ↗
• MalfunctionFeb 15, 2026Suction Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE VITRECTOMY PROBE HAD NO ASPIRATION BEFORE THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY. THE OTHER SURGERY DETAILS AND PATIENT DETAILS WERE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24341622 ↗
• MalfunctionFeb 10, 2026Failure to Cut

  A NURSE REPORTED THAT PROBE HAS POOR CUTTING BEFORE VITRECTOMY SURGERY. THE ASPIRATION CONDITION 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 24301843 ↗
• MalfunctionFeb 9, 2026Failure to Cut

  A NURSE REPORTED THAT VITRECTOMY PROBE HAD POOR CUTTING AND THE ASPIRATION WAS NORMAL BEFORE THE 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 24292945 ↗
• MalfunctionFeb 9, 2026Failure to Cut

  A NURSE REPORTED THAT PROBE HAD POOR CUTTING 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 24288790 ↗
• MalfunctionJan 30, 2026Failure to Cut

  A HEALTH CARE PROFESSIONAL REPORTED THAT VITRECTOMY PROBE HAD POOR CUTTING BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY, BUT IT WAS UNKNOWN HOW THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223094 ↗
• MalfunctionJan 30, 2026Failure to Cut

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219599 ↗
• MalfunctionJan 17, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT THE PROBE HAD NO CUTTING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24105364 ↗
• MalfunctionJan 8, 2026Failure to Cut; Air/Gas in Device

  A NURSE REPORTED THAT PROBE KEPT EMITTING BUBBLES, CUTTER COULD NOT BE CLOSED DURING OPENING STATE, MAKING IT IMPOSSIBLE TO COMPLETE THE 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 24000748 ↗
• MalfunctionDec 26, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THE PROBE COULD 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 23901294 ↗
• MalfunctionDec 16, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THE PROBE COULD NOT CUT DURING VITRECTOMY SURGERY. THE ASPIRATION FUNCTION 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 23813437 ↗
• MalfunctionDec 10, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THE VITRECTOMY PROBE HAD INTERMITTENT CUTTING 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 23766588 ↗
• MalfunctionDec 3, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THE PROBE HAD POOR CUTTING 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 23702685 ↗
• MalfunctionNov 19, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT VITRECTOMY PROBE HAD POOR CUTTING 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 23590691 ↗
• MalfunctionNov 14, 2025Suction Problem; Suction Problem

  A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT THE VITRECTOMY PROBE DID NOT ASPIRATE, STOP USING IMMEDIATELY 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 23555824 ↗
• MalfunctionNov 14, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT PROBE COULD NOT CUT AND THE ASPIRATION WAS NORMAL BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY REPLACING WITH ANOTHER PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23552187 ↗
• MalfunctionNov 11, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THE PROBE COULD NOT CUT BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY 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 23523318 ↗
• MalfunctionNov 11, 2025Failure to Cut; Failure to Cut

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT VIA REGULATORY AUTHORITY THAT PROBE HAD POOR CUTTING DURING VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED ON SAME DAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23522399 ↗