Constellation, Ultravit, 27+, TotalPlus, EdgePlus 8065752062Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380657520626), received between Aug 9, 2023 and May 10, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2024Failure to Cut; Failure to Cut

  A HEALTH AUTHORITY REPORTED THAT THE PROBE HAD POOR CUTTING PERFORMANCE DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PROBE WITH ANOTHER PROBE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19294607 ↗
• MalfunctionAug 24, 2023Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THE PROBE DID NOT CUT AT AN UNKNOWN TIMING. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17610374 ↗
• MalfunctionAug 9, 2023Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED CUTTER WAS IN BAD CONDITION AND ACTUATION FAILURE OCCURRED DURING VITRECTOMY SURGERY. THE CONDITION OF ASPIRATION WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17488202 ↗