Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752439Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00380657524396), received between Mar 23, 2021 and May 29, 2026 — classified as 3 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (36 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 28, 2025Class IIOpen, Classified

   Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.

   Z-2108-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE WAS POOR CUTTING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25326791 ↗
• MalfunctionFeb 18, 2026Failure to Cut

  A PHARMACIST REPORTED THAT THE VITRECTOME CUTTING MECHANISM WAS LOCKED UP DURING VITRECTOMY SURGERY. THE ASPIRATION FUNCTION WAS NORMAL. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE VITRECTOMY PROBE WITH ANOTHER ONE. THE VITREOTOME CAME INTO CONTACT WITH THE PATIENT¿S EYE BUT THERE WERE NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24374822 ↗
• MalfunctionFeb 13, 2026Suction Problem

  A PHYSICIAN REPORTED THAT VACUUM OF THE FLUIDICS MANAGEMENT SYSTEM WAS NOT WORKING FOR THE REPORTED CASSETTE DURING VITRECTOMY SURGERY. THEY HAVE TO CHANGE TO A NEW ONE IN ORDER FOR SURGERY TO BE COMPLETED. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24334158 ↗
• MalfunctionJan 27, 2026Failure to Cut

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT PROBE HAD POOR CUTTING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING WITH ANOTHER PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24190795 ↗
• MalfunctionJan 12, 2026Failure to Cut

  AN HEALTH CARE PROFESSIONAL REPORTED THAT THE VITREOUS PROBE HAD POOR CUTTING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24034225 ↗
• MalfunctionNov 25, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT THE ASPIRATION OF A PROBE WAS WEAK DURING VITRECTOMY SURGERY. THE ISSUE DID NOT RESOLVE EVEN AFTER LOWERING THE CUTTING RATE. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE CONDITION OF CUTTING AND ACTUATION WAS UNKNOWN. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646846 ↗
• InjuryOct 14, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THE PROBE HAD POOR CUTTING PERFORMANCE DURING SURGERY. THE PATIENT EXPERIENCED MINIMAL BLEEDING. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO PATIENT IMPACT.

  Patient problems: Hyphema

  MAUDE report 23275984 ↗
• MalfunctionSep 17, 2025Failure to Cut; Failure to Cut

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT VITRECTOMY PROBE HAD POOR CUTTING, AND THE ASPIRATION WAS NORMAL DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070583 ↗
• MalfunctionSep 17, 2025Failure to Cut; Failure to Cut

  A HEALTH CARE PROFESSIONAL REPORTED THAT PROBE HAD POOR CUTTING PERFORMANCE DURING VITRECTOMY SURGERY. THE ASPIRATION WAS WORKING NORMALLY. THE SURGERY WAS COMPLETED AFTER CHANGED A NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23069988 ↗
• MalfunctionSep 8, 2025Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT THE PRODUCT HAD INSUFFICIENT POWER WHEN CONNECTED TO THE HOST, MAKING IT IMPOSSIBLE TO PERFORM NORMAL CUTTING FUNCTION BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993767 ↗
• MalfunctionSep 4, 2025Failure to Cut; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT VITRECTOMY PROBE COULD NOT CUT BEFORE THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY. THE OTHER SURGERY DETAILS WERE UNKNOWN. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22965879 ↗
• InjurySep 3, 2025Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED VIA HEALTH AUTHORITY AS WELL AS TO THE QUALITY DEPARTMENT OF THE COMPANY THAT THE TIP OF THE VITRECTOMY PROBE BROKE IN THE LEFT EYE OF THE MALE PATIENT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH AN EMERGENCY TREATMENT AND AFTER CHANGING THE PROBE TO A NEW ONE. PATIENT INJURY WAS CAUSED DURING THE SURGERY BUT NO FURTHER DETAILS REGARDING THE INJURY OR CURRENT PATIENT CONDITION WAS OBTAINED.

  Patient problems: Eye Injury

  MAUDE report 22951557 ↗
• MalfunctionAug 26, 2025Failure to Cut; Failure to Cut

  A HEALTH CARE PROFESSIONAL REPORTED THAT PROBE HAD POOR CUTTING PERFORMANCE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER CHANGED A NEW ONE. THE ASPIRATION WAS NORMAL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897088 ↗
• MalfunctionAug 14, 2025Suction Problem; Suction Problem

  A HEALTHCARE PROFESSIONAL REPORTED VITRECTOMY CUTTER TIP HAD INSUFFICIENT SUCTION BEFORE VITRECTOMY SURGERY. THE SURGERY DETAILS WERE UNKNOWN. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22805955 ↗
• MalfunctionAug 6, 2025Failure to Cut; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE PROBE HAD POOR CUTTING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22724856 ↗
• MalfunctionAug 5, 2025Failure to Cut; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE PROBE HAD POOR CUTTING DURING VITRECTOMY SURGERY. REPLACED WITH A NEW PROBE AND COMPLETED THE SURGERY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22712515 ↗
• MalfunctionAug 3, 2025Failure to Cut; Failure to Cut

  A HEALTH CARE PROFESSIONAL REPORTED THAT PROBE POOR CUTTING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22696042 ↗
• MalfunctionJun 12, 2025Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT THE PROBE COULD NOT ASPIRATE DURING VITRECTOMY SURGERY. THE CONDITION OF ACTUATION AND CUTTING WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22192197 ↗
• MalfunctionMay 30, 2025Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT THE ASPIRATION FAILURE OF THE PROBE OCCURRED, AND THE VITRECTOMY CUTTER COULD NOT ASPIRATE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE VITREOUS CUTTER WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22112122 ↗
• MalfunctionMay 12, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE CUTTER WAS DEFECTIVE AND DID NOT ACTUATE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22007550 ↗
• MalfunctionMay 12, 2025Leak/Splash; Leak/Splash

  AN OPHTHALMIC SURGEON REPORTED THAT THE VALVES (TROCARS) WERE LEAKING DURING PARS PLANA VITRECTOMY AND ENDO LASER SURGERY IN A MALE PATIENT. THE SURGEON USED ANOTHER PAK TO COMPLETE SURGERY. THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT PERTAINS TO ENTRY SYSTEM (TROCAR) INVOLVED IN REPORTED EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22000500 ↗
• MalfunctionMay 2, 2025Failure to Cut; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE PROBE COULD NOT CUT DURING VITRECTOMY SURGERY. THE ASPIRATION CONDITION WAS NORMAL. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21948853 ↗
• MalfunctionMay 2, 2025Failure to Cut; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED VITRECTOR PROBE HAS POOR CUTTING PERFORMANCE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21948141 ↗
• MalfunctionMar 19, 2025Failure to Cut; Failure to Cut

  AN OTHER HEALTHCARE PROFESSIONAL REPORTED THAT POOR CUTTING OF PROBE WAS OBSERVED DURING VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21640589 ↗
• MalfunctionMar 19, 2025Failure to Cut; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE VITRECTOMY PROBE COULD NOT CUT DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21640030 ↗