Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751768Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380657517688), received between Mar 29, 2021 and Sep 9, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2024Suction Failure; Suction Failure

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT VALVE DID NOT ASPIRATE AT AN UNKNOWN TIMING. PROCEDURE TYPE AND COMPLETION WERE UNKNOWN. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20169800 ↗
• MalfunctionDec 22, 2023Material Twisted/Bent; Material Twisted/Bent

  AN OTHER HEALTHCARE PROFESSIONAL REPORTED THAT CUTTER TIP WAS BENT BEFORE THE SURGERY. THE SURGERY WAS COMPLETED BY REPLACING THE CUTTER. THERE WAS NO PATIENT CONTACT. THE PROCEDURE TYPE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18388741 ↗
• MalfunctionJul 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A NURSE REPORTED THAT WATER LEAKAGE FROM THE CASSETTE BEFORE SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17246118 ↗
• MalfunctionMay 16, 2023Suction Failure; Suction Failure

  A CUSTOMER REPORTED THAT LOW SUCTION POWER WAS DETECTED IN BOTH THE HANDPIECE AND THE ASPIRATION IRRIGATION (AI) PART DURING THE VITRECTOMY SURGERY. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NONE HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16936889 ↗
• MalfunctionJan 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A NURSE REPORTED TEST FAILED, LEAKING WATER FROM THE CARTRIDGE WHILE PRIMING. THE PRODUCT WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16119905 ↗
• MalfunctionFeb 25, 2022Suction Failure; Suction Failure

  A NURSE REPORTED ASPIRATION FAILED DURING A VITRECTOMY SURGERY. THE PRODUCT WAS REPLACED AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13597694 ↗
• MalfunctionOct 2, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A NURSE REPORTED THE WATER LEAKED FROM THE CASSETTE BEFORE A VITRECTOMY PROCEDURE. THE CASSETTE WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED. THIS OCCURRED TWICE AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12566359 ↗
• MalfunctionAug 27, 2021Difficult to Insert; Difficult to Insert

  A CUSTOMER REPORTED A TROCAR COULD NOT ENTER PATIENT'S EYE DURING A PROCEDURE. THE STATUS OF THE PATIENT IS NOT KNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 12380025 ↗
• MalfunctionJul 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A NURSE REPORTED WATER WAS LEAKING FROM A CASSETTE BEFORE A VITRECTOMY PROCEDURE. THE PRODUCT WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12127743 ↗
• MalfunctionMar 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A NURSE REPORTED THE CASSETTE LEAKED DURING PRIMING FOR A VITRECTOMY PROCEDURE. THE PRODUCT WAS REPLACED WITH ANOTHER ONE AND THEY WERE ABLE TO PROCEED AND THE PLANNED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11592721 ↗
• MalfunctionMar 29, 2021Difficult to Remove; Difficult to Remove

  A CUSTOMER REPORTED THAT THE INFUSION SLEEVE WAS VERY THICK AND BECAME STUCK IN THE CORNEAL INCISION DURING A PROCEDURE. CORNEAL INCISION WAS ENLARGED WITH 2.8MM CORNEAL BLADE BUT STILL GETTING STUCK. THE PRODUCT WAS REPLACED AND PROCEDURE COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11582784 ↗