CONSTELLATION HYPERVIT ENGAUGE 8065830027Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00380658300272), received between Nov 3, 2021 and Sep 17, 2026 — classified as 1 injury, 54 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (36 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Failure to Cut

  A nurse reported that that vitrectomy probe could not cut during vitrectomy surgery. The surgery was completed on same day by replacing it with new product. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797379 ↗
• InjurySep 4, 2026Failure to Cut

  A physician reported that the vitreous was not being adequately cut. After the cutter was replaced, the issue was resolved. During peripheral retinal examination following vitrectomy, two retinal tears were identified in the inferior peripheral retina. During intraoperative laser treatment, No retinal detachment was observed. Treatment was completed with laser.

  Patient problems: Retinal Tear

  MAUDE report 50613744 ↗
• MalfunctionAug 13, 2026Suction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50234796 ↗
• MalfunctionJun 26, 2026Failure to Cut

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25632444 ↗
• MalfunctionJun 26, 2026Failure to Cut

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25632443 ↗
• MalfunctionFeb 27, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT THE FAILURE OF CUTTER (CUTTING ISSUE) DURING SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY, BUT IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24468410 ↗
• MalfunctionFeb 9, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT THE CUTTER DID NOT ACTUATE AT FIRST. THE CONNECTOR OF CUTTER SLIGHTLY LIFTED FROM THE CONSOLE. WHEN IT WAS PHYSICALLY INSERTED INTO THE CONSOLE, THE CUTTER COULD BE USED. IT WAS UNCLEAR WHETHER THE CUTTER JUST HAPPENED TO WORK AT THAT MOMENT OR WHETHER IT WORKED BECAUSE THE CONNECTOR WAS PUSHED IN DURING THE VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED ON THE SAME DAY AND THE PRODUCT CONTINUED TO BE USED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289211 ↗
• MalfunctionFeb 6, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT CUTTER STOPPED MOVING DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH THE SAME PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275889 ↗
• MalfunctionJan 30, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT CUTTING COULD NOT BE PERFORMED DURING SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223093 ↗
• MalfunctionJan 20, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT CUTTING FAILURE OCCURRED DURING SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE SURGERY TYPE WAS UNKNOWN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24113798 ↗
• MalfunctionJan 20, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT POOR ACTUATING OF PROBE OCCURRED DURING CATARACT/VITRECTOMY COMBINATION SURGERY. THE CONDITION OF ASPIRATING 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 24113796 ↗
• MalfunctionJan 6, 2026Suction Problem

  A PHYSICIAN REPORTED THAT ABNORMAL ASPIRATION DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH ANOTHER PRODUCT. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973369 ↗
• MalfunctionJan 6, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT CUTTER DID NOT CUT DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING WITH ANOTHER PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23972118 ↗
• MalfunctionDec 29, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT CUTTER DID NOT CUT DURING SURGERY. THE PROCEDURE TYPE 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 23904595 ↗
• MalfunctionDec 24, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT CUTTER COULD NOT CUT BEFORE THE SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY. OTHER SURGERY DETAILS WERE UNKNOWN. THE PRODUCT WAS NOT CONTACTED WITH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23886859 ↗
• MalfunctionDec 22, 2025Suction Problem; Suction Problem

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

  Patient problems: Insufficient Information

  MAUDE report 23861951 ↗
• MalfunctionDec 13, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT CUTTER COULD NOT CUT DURING THE CATARACT AND VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY. HOW SURGERY COMPLETED WAS UNKNOWN. THE PRODUCT WAS CONTACTED WITH PATIENT BUT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23797849 ↗
• MalfunctionDec 5, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT POOR ASPIRATION OF CUTTER WAS CONFIRMED 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 23725953 ↗
• MalfunctionDec 4, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT THE ASPIRATION COULD NOT BE USED DURING THE SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY. THE OTHER SURGERY DETAILS WERE UNKNOWN. THE PRODUCT CONTACTED WITH PATIENT, BUT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23712727 ↗
• MalfunctionDec 1, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT VITRECTOMY PROBE HAD POOR ASPIRATION DURING THE CATARACT AND VITRECTOMY COMBINATION 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 23677865 ↗
• MalfunctionDec 1, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE PROBE WAS NOT SHARP ENOUGH DURING CATARACT AND VITRECTOMY COMBINATION SURGERY. THE PROCEDURE WAS COMPLETED ON SAME DAY AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677651 ↗
• MalfunctionNov 28, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE PROBE WAS NOT SHARP ENOUGH DURING CATARACT AND VITRECTOMY COMBINATION SURGERY. THE PROCEDURE WAS COMPLETED ON SAME DAY, BUT THE DETAILS WERE UNKNOWN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23672061 ↗
• MalfunctionNov 6, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT WHEN PRESSED THE FOOT SWITCH, CUTTER ASPIRATION STOPPED OCCURRED DURING SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE PRODUCT. THE SURGERY TYPE WAS UNKNOWN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493417 ↗
• MalfunctionNov 4, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT ACTUATION AND CUTTING FAILURES OF A PROBE OCCURRED DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE CONDITION OF ASPIRATION WAS UNKNOWN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23472878 ↗
• MalfunctionNov 4, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT ASPIRATION FAILURE OF A PROBE OCCURRED DURING CATARACT AND VITRECTOMY COMBINATION SURGERY. A TEST WAS PASSED, HOWEVER, AFTER USING THE PRODUCT FOR A WHILE, ASPIRATION WAS NOT PERFORMED. THE CONDITION OF ACTUATION AND CUTTING 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 23462089 ↗