Constellation, Ultravit, TotalPlus, EdgePlus 8065751614Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380657516148), received between Jun 15, 2021 and Oct 16, 2025 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT PROBE STOPPED CUTTING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY CHANGING THE NEW PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23308423 ↗
• MalfunctionOct 16, 2025Failure to Cut; Failure to Cut

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23307901 ↗
• MalfunctionAug 27, 2024Dull, Blunt; Dull, Blunt

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT THE PHYSICIAN HAD ISSUES WITH THE TROCAR WHICH WAS NOT STABLE ON THE SCLERA AND HAD DIFFICULTIES TO ENTER THE EYE OF THE MALE PATIENT DURING VITRECTOMY SURGERY (WITHOUT INTRA OCULAR LENS IMPLANTATION) DELAYING THE SURGERY BY SOME TIME. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE CASSETTE. THERE WAS PATIENT CONTACT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20074370 ↗
• MalfunctionAug 6, 2024Failure to Cut; Suction Failure; Failure to Cut; Suction Failure

  A CUSTOMER REPORTED VITRECTOR NOT CUTTING AND NO SUCTION WITH UNKNOWN TIMING. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 19916001 ↗
• MalfunctionJul 8, 2024Suction Failure; Suction Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS NO VACUUM DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE VITRECTOR WITH NEW ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19688955 ↗
• MalfunctionJul 5, 2024Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THE PROBE STOPPED CUTTING DURING SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PROBE WITH NEW ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19678797 ↗
• MalfunctionJun 24, 2024Suction Failure; Suction Failure

  THE OTHER HEALTH CARE PROFESSIONAL REPORTED THAT THE CUTTER WAS CUTTING BUT IT DID NOT HAVE ANY SUCTION FOR CATARACT SURGERY WITH INTRAOCULAR IMPLANT. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING WITH ANOTHER PROBE.. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19593076 ↗
• MalfunctionJun 13, 2024Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  A NURSE REPORTED THAT THE TUBE CONNECTION WAS NOT TIGHT AND BUBBLES IN TUBE, LIQUID LEAKAGE AT THE INTERFACE OF THE TUBE CONNECTED TO CASSETTE OCCURRED BEFORE SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED AND SPECIFIED THAT THE ISSUE WAS HAPPENED DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19526035 ↗
• MalfunctionApr 30, 2024Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  A NURSE REPORTED THAT THE RUBBER ON THE BACK OF CASSETTE HAS FALLEN OFF AND THE BALANCED SALT SOLUTION CONTINUES TO LEAK BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE CASSETTE WITH ANOTHER CASSETTE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19213204 ↗
• MalfunctionFeb 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A HEALTH CARE PROFESSIONAL REPORTED THAT CASSETTE WAS LEAKING BELOW THE INFUSION LINE DURING CALIBRATION. THE SURGERY WAS COMPLETED BY REPLACING WITH ANOTHER PAK. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754815 ↗
• MalfunctionOct 5, 2023Suction Failure; Suction Failure

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE VITRECTOR STOPPED WORKING AND NOT SUCKING DURING SURGERY. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THAT 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 17875100 ↗
• MalfunctionJun 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN REPORTED THAT THE VITRECTOR HANDLE CAME APART AND HARD AIR SOUND NOISE WAS OBSERVED DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17169748 ↗
• 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 SINCE THE DOCTOR WAS USING A CONTACT LENS AS INVERTER AND THE BALANCE SALT SOLUTION (BSS) COMING OUT FROM THE TROCAR WAS FALLING ON THE LENS RESULTING IN BLURRY LENS. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REPRESENTATIVE THAT THERE WAS NO HARM OCCURRED TO THE PATIENT. ALSO IT WAS CLARIFIED THAT THE LENS WAS BLURRY THROUGH OUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16661856 ↗
• MalfunctionNov 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A NURSE REPORTED THAT AFTER THE LOADING OF THE THREE TROCARS ON THE SCLERA IT WAS NOTICED THAT ALL TROCARS HAD A BIG LEAKAGE DURING A VITRECTOMY OPERATION WITHOUT IOL (INTRAOCULAR LENS) IMPLANTATION. THE DOCTOR DECIDED TO CONTINUE AND THE OPERATION WAS COMPLETED SUCCESSFULLY WITH SOME DIFFICULTIES SINCE THE DOCTOR WAS USING A CONTACT LENS AS INVERTER AND THE BSS (BALANCED SALT SOLUTION) COMING OUT FROM THE TROCAR WAS FALLING ON THE LENS RESULTING IN BLURRY LENS. ADDITIONAL INFORMATION WAS RECEIVED. ¿THE DOCTOR WAS USING A CONTACT LENS AS AN INVERTER AND THE BSS COMING OUT FROM THE TROCAR WAS FALLING ON THE LENS RESULTING IN BLURRY LENS¿ SO BY ¿BLURRY LENS¿ SHE WAS NOT REFERRING TO THE PATIENT'S PHYSICAL LENS BUT TO THE CONTACT LENS USED BY THE DOCTOR. THIS CONTACT LENS BECAME BLURRY FROM THE BSS THAT WAS COMING OUT FROM THE TROCAR SO THE DOCTOR HAD DIFFICULTIES TO SEE THROUGH THE LENS." THERE WAS NO CHANGE IN THE REGULATORY DECISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15844134 ↗
• MalfunctionAug 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A NURSE REPORTED THAT ONE OF THE TROCARS AMONG THE THREE LOADED ON THE SCLERA HAD LEAKAGE, THE DOCTOR NOTICED LEAKAGE DURING THE VITRECTOMY PROCEDURE. THE PROCEDURE WAS CARRIED ON AND WAS COMPLETED SUCCESSFULLY WITH SOME DIFFICULTIES. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15183907 ↗
• MalfunctionJul 9, 2022Failure to Cut; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT CUTTERS WERE CUTTING INTERMITTENTLY AND THEN THERE WAS NO CUTTING. PROBLEM WAS WITH THE PNEUMATIC ASSEMBLY PANEL THAT HAD BEEN REPLACED. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14973667 ↗
• InjuryMay 20, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A NURSE REPORTED THAT ONE OF THE TROCARS HAD A LEAKAGE AND PART OF THE RETINA WAS TRAPPED IN THE TROCAR RESULTING IN THE CREATION OF ANOTHER HOLE ON THE RETINA APART FROM THE EXISTING RETINAL HOLE DUE TO TRAUMA DURING THE VITRECTOMY PROCEDURE. THE SURGEON SUCCESSFULLY MANAGED TO RELEASE THE RETINA FROM THE TROCAR. THE SURGEON DECIDED TO CONTINUE THE PROCEDURE WITH THE SAME CASSETTE DUE TO THE FACT THAT THE PATIENT HAD A TRAUMA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Retinal Tear

  MAUDE report 14461479 ↗
• MalfunctionMay 5, 2022Failure to Cut; Failure to Cut

  A NURSE REPORTED CUTTER DID NOT CUT DURING A VITRECTOMY PROCEDURE. THE ASPIRATION WAS WORKING. THE PROCEDURE WAS COMPLETED AFTER THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14287639 ↗
• 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 ONE OF TWO REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12931561 ↗
• MalfunctionJun 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A NURSE REPORTED TROCAR LEAKAGE DURING SURGERY. THE CASSETTE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12001682 ↗