Constellation, ULTRAVIT, EdgePlus, TotalPlus 8065752448Recalls & reported problems

Summary

The FDA's MAUDE database contains 206 adverse event reports that list this exact device (DI 00380657524488), received between Mar 10, 2021 and Aug 14, 2026 — classified as 5 injuries, 201 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (167 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 28, 2025Open, 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-2109-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 206 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50251388 ↗
• MalfunctionAug 14, 2026Suction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50249815 ↗
• MalfunctionAug 11, 2026Use of Device Problem

  A non- healthcare professional reported that cutter in the surgical pack was not functioning and could not be used during vitrectomy surgery. The surgery was successfully completed on same day, but it was unknown how the surgery was completed. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209225 ↗
• MalfunctionAug 10, 2026Fluid/Blood Leak

  Patient problems: Insufficient Information

  MAUDE report 50194558 ↗
• MalfunctionAug 10, 2026Failure to Cut

  A nurse reported that the self-closing cannulae leaked fluid. The probe could not cut before the vitrectomy surgery. The surgery completed on same day but unknow how it was completed. No information about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50194557 ↗
• MalfunctionAug 10, 2026Failure to Cut

  A healthcare professional reported that probe would not be cut. The surgery type was vitrectomy surgery. The surgery was completed on same day. The other surgery details were unknown. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50194556 ↗
• MalfunctionJun 4, 2026Failure to Cut

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT PROBE DID NOT CUT AT DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY OPENING NEW PACK. THERE WAS PATIENT CONTACT DURING THE VITREOUS REMOVAL PHASE BUT NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 25388681 ↗
• MalfunctionMay 26, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE COULD NOT CUT BEFORE CATARACT/VITRECTOMY COMBINATION 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 25280344 ↗
• MalfunctionMay 15, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE HAD POOR CUTTING BEFORE VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT THE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186083 ↗
• MalfunctionApr 2, 2026Suction Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS NO ASPIRATION FROM THE ANTERIOR VITRECTOMY CUTTER DESPITE FLUSHING THOUGH THE DEVICE DURING VITRECTOMY SURGERY. ANOTHER PACK WAS OPENED TO RETRIEVE THE ANTERIOR CUTTER WHICH WAS THEN PRIMED AND CASE PROCEEDED AS PLANNED. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24762726 ↗
• MalfunctionMar 5, 2026Failure to Cut

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT VITRECTOMY PROBE COULD NOT CUT DURING VITRECTOMY SURGERY. THE SURGERY WAS PERFORMED AND 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 24518754 ↗
• MalfunctionMar 4, 2026Improper Flow or Infusion

  A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT THERE WAS NO GAS OR WATER IN AND OUT FROM THE GAS-LIQUID EXCHANGE TUBE, WHICH CAUSED THE TEST TO FAIL BEFORE CATARACT AND VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH SAME PRODUCT. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505563 ↗
• MalfunctionMar 2, 2026Suction Problem; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT CUTTER NOT WORKING (CUTTING AND ASPIRATION WERE NOT WORKING) DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE PAK. THE PRODUCT WAS CONTACTED WITH PATIENT, BUT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24481534 ↗
• InjuryFeb 23, 2026Leak/Splash

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT CASSETTE LEAKAGE OCCURRED DURING THE COMBINED CATARACT/VITRECTOMY PROCEDURE. THE SURGERY COULD NOT BE COMPLETED THE SAME DAY AND WAS RESCHEDULED THREE DAYS LATER, AFTER WHICH IT WAS COMPLETED. DETAILS REGARDING HOW THE SUBSEQUENT PROCEDURE WAS PERFORMED AND THE PATIENT¿S CURRENT CONDITION REMAIN UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24411694 ↗
• MalfunctionFeb 20, 2026Break

  A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT THE PROBE WAS BROKEN BEFORE VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED ON SAME DAY BY REPLACING THE PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401051 ↗
• MalfunctionFeb 19, 2026Failure to Cut

  A HEALTH CARE PROFESSIONAL REPORTED THAT PROBE HAD NO CUTTING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING WITH ANOTHER PACK. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24386432 ↗
• MalfunctionFeb 12, 2026Failure to Cut

  A CUSTOMER REPORTED THAT THE OCUTOME (PROBE) COULD NOT CUT DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED AND NON-RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322345 ↗
• MalfunctionFeb 10, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT THE PROBE HAD NO CUTTING SPEED, EVEN THOUGH THE EQUIPMENT DISPLAYED A NORMAL CUTTING SPEED. EVEN WHEN THE CUTTING SPEED WAS REDUCED TO 5000, THERE WAS STILL NO CUTTING DURING VITRECTOMY AND COMBINATION 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 24301844 ↗
• MalfunctionFeb 6, 2026Suction Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT PRODUCT DID NOT REMOVE THE VITREOUS AT AN UNKNOWN TIMING. THE PROCEDURE TYPE AND COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24276861 ↗
• MalfunctionFeb 3, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT VITREOUS CANNOT BE TAKEN BY THE OCUTOME AT AN UNKNOWN TIMING. THE SURGERY DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24243688 ↗
• MalfunctionFeb 3, 2026Suction Problem

  A CUSTOMER REPORTED THAT THE VITREOUS COULD NOT BE TAKEN BY THE OCUTOME AT AN UNKNOWN TIMING. THE PROCEDURE TYPE AND SURGERY COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24243343 ↗
• MalfunctionFeb 2, 2026Failure to Cut

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

  Patient problems: Insufficient Information

  MAUDE report 24232700 ↗
• MalfunctionJan 30, 2026Failure to Cut

  A NURSE REPORTED THAT THE VITRECTOMY PROBE COULD CUT AT BEGINNING BUT STOPPED CUTTING HALFWAY DURING VITRECTOMY SURGERY. THE OTHER SURGERY DETAILS WERE UNKNOWN. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220684 ↗
• MalfunctionJan 28, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE HAD POOR CUTTING AND THE ISSUE COULD NOT BE SOLVED EVEN REDUCING THE CUTTING SPEED BEFORE THE CATARACT AND VITRECTOMY COMBINATION 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 24197523 ↗
• MalfunctionJan 27, 2026Suction Problem; Failure to Cut

  A NURSE REPORTED THAT PROBE HAD POOR CUTTING AND WAS UNABLE TO CUT AFTER CUTTING FOR A WHILE AND THERE WAS NO ASPIRATION DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY CHANGING THE PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191943 ↗