Constellation, Ultravit, TotalPlus, EdgePlus 8065751766Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380657517664), received between Dec 5, 2021 and Nov 22, 2024 — classified as 10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2024Leak/Splash; Leak/Splash

  THE NURSE REPORTED THAT CASSETTE WAS LEAKING BEFORE THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY. THERE WAS NO SPECIFIC IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20756701 ↗
• MalfunctionJul 1, 2024Leak/Splash; Misconnection; Leak/Splash; Misconnection

  A NURSE REPORTED THAT AFTER LOADING OF THREE TROCARS ON THE SCLERA, THERE WAS A SILICONE OIL LEAKAGE FROM THE TROCARS AND ALSO FROM TROCAR SCLERAL INCISIONS DURING VITRECTOMY OPERATION WITH INTRAOCULAR IMPLANTATION AND WITH SILICON OIL REMOVAL. IT WAS ALSO REPORTED THAT THE TROCARS WERE VERY LOOSE. THE OPERATION WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643492 ↗
• MalfunctionMay 1, 2024Suction Failure; Suction Failure

  A NURSE REPORTED THAT THE ASPIRATION WAS NOT WORKING EFFICIENTLY AND ADVISORY MESSAGE FOR ASPIRATION WHEN THE DOCTOR STARTED WITH THE VITREOUS REMOVAL. THE DOCTOR REQUESTED FROM THE NURSE TO REPLACE THE CASSETTE WITH A NEW CASSETTE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19223703 ↗
• MalfunctionMar 12, 2024Leak/Splash; Unstable; Leak/Splash; Unstable

  A NURSE REPORTED THAT TROCAR LEAKAGE AND IT WAS NOT STABLE AT INCISION DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18886778 ↗
• MalfunctionJul 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A CUSTOMER REPORTED THAT WATER COMES OUT OF THE CASSETTE DURING THE SURGERY. THERE NO REPORT OF PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NONE HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298390 ↗
• MalfunctionJun 26, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  A CUSTOMER REPORTED THAT THE TUBE WAS DISCONNECTED FROM THE CONNECTOR DURING SURGERY. THE PROCEDURE DETAILS WAS NOT REPORTED. THERE WAS NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17200296 ↗
• MalfunctionMay 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A NURSE REPORTED THAT THERE WAS A LEAK OBSERVED INSIDE THE CASSETTE AT THE INFUSION CONNECTOR AND ALSO THE BALANCED SALT SOLUTION (BSS) KEPT FALLING FROM THE BSS BOTTLE THROUGH THE SPIKE CONNECTOR INTO THE DRIP CHAMBER DURING VITRECTOMY SURGERY. THERE WAS NO ERROR OR ADVISORY MESSAGE WAS DISPLAYED ON THE SCREEN. THE SURGERY WAS COMPLETED AFTER REPLACING THE CASSETTE WITH NEW ONE. THE PATIENT HARM WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16988589 ↗
• MalfunctionApr 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A NURSE REPORTED AFTER THE LOADING OF THE TROCARS ON THE SCLERA IT WAS NOTICED THAT ALL TROCARS FOR THE INSTRUMENTATION HAD A BIG LEAKAGE DURING VITRECTOMY SURGERY. THE OPERATION WAS COMPLETED SUCCESSFULLY WITH SOME DIFFICULTIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16661593 ↗
• MalfunctionJun 30, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A NURSE REPORTED TROCAR LEAKAGE DURING A VITRECTOMY SURGERY. THE PRODUCT WAS NOT REPLACED AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14872604 ↗
• MalfunctionDec 5, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A NURSE REPORTED A TROCAR CANNULA LEAKED DURING A PROCEDURE. THE PRODUCT WAS REPLACED WITH ANOTHER ONE AND IT LEAKED. HOWEVER, THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON WHO INDICATED ONLY ONE TROCAR LEAKED DURING THE FLUID AIR EXCHANGE PHASE OF THE PROCEDURE WHICH OBSCURED SURGEON¿S VIEW. THIS IS TWO OF TWO REPORTS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12931560 ↗