CONSTELLATION® ULTRAVIT® ENGAUGE® 8065750948Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380657509485), received between Jun 30, 2022 and Aug 3, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2022Failure to Cut; Air/Gas in Device; Failure to Cut; Air/Gas in Device

  A NURSE REPORTED PROBE KEPT BUBBLING DURING THE CUTTING PROCESS, THE CUTTING WAS NOT COMPLETE AND WIRE DRAWING OCCURS DURING A VITRECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15154713 ↗
• MalfunctionJun 30, 2022Failure to Cut; Failure to Cut

  A NURSE REPORTED A VITRECTOMY PROBE WAS STRINGY AND COULD NOT CUT DURING THE VITRECTOMY PROCEDURE. THE PRODUCT WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED FROM THE COMPANY REPRESENTATIVE INDICATING ASPIRATION WAS FUNCTIONING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14874537 ↗