Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752435Recalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 00380657524358), received between Mar 4, 2021 and Sep 30, 2026 — classified as 4 injuries, 122 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (71 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 126 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Cut

  A non-health care professional reported that the vitrectomy cutter would barely cut and only aspirate during vitrectomy surgery. The surgery completed on the same day after multiple different cutters were attempted to be used. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944981 ↗
• MalfunctionSep 29, 2026Suction Problem; Ambient Noise Problem

  A nurse reported that the vitrectomy probe had abnormal noise and no negative pressure 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 50934791 ↗
• MalfunctionAug 14, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50250653 ↗
• MalfunctionAug 13, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50232165 ↗
• MalfunctionAug 11, 2026Suction Problem

  Patient problems: Insufficient Information

  MAUDE report 50206612 ↗
• MalfunctionMay 13, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE COULD NOT CUT BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159177 ↗
• MalfunctionFeb 2, 2026Infusion or Flow Problem

  A PHYSICIAN REPORTED THAT THERE WAS NO FLOW FROM INFUSION LINE DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS PATIENT CONTACT BUT NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232042 ↗
• MalfunctionJan 7, 2026Suction Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT PROBE HAD NO ASPIRATION, AND CUTTING WAS NORMAL 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 23987591 ↗
• MalfunctionJan 5, 2026Suction Problem; Air/Gas in Device

  A PHYSICIAN REPORTED THAT SMALL BUBBLES CAN BE SEEN FORMING AND EXITING THE VITRECTOMY PROBE WITHOUT ANY VITREOUS ASPIRATION DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY, AFTER REPLACING THE PACK WITH A NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956932 ↗
• MalfunctionJan 5, 2026Failure to Cut

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE VITRECTOMY PROBE HAD POOR CUTTING DURING VITRECTOMY SURGERY. 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 23955745 ↗
• MalfunctionDec 22, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE CUTTING FUNCTION DID NOT APPEAR TO WORK PROPERLY, MAKING PERIPHERAL VITRECTOMY INEFFECTIVE AND CAUSING TRACTION DURING VITRECTOMY SURGERY. THE CONDITION OF ASPIRATION WAS NORMAL. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT ON THE PATIENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AS THERE WAS NO CONSENT TO FOLLOW UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874364 ↗
• MalfunctionDec 9, 2025Leak/Splash; Leak/Splash

  A PHARMACIST REPORTED THAT THE LEAKAGE OCCURRED OUTSIDE THE CASSETTE WITHOUT ANY ALERT MESSAGE BEFORE SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THIS ISSUE CAUSED A DELAY IN THE PROCEDURE BUT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757536 ↗
• MalfunctionDec 9, 2025Failure to Cut; Failure to Cut

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT SUDDENLY CUTTING FUNCTION WAS STOPPED AND THEN IT WAS INSTRUCTED TO REDUCE THE CUTS PER MINUTE TO FIVE THOUSAND DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BUT REPLACEMENT DETAILS WERE UNKNOWN THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23754416 ↗
• MalfunctionDec 9, 2025Failure to Cut; Failure to Cut

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PROBE SUDDENLY STOPPED THE CUTTING FUNCTION DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY LOWERING ITS SPEED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23753690 ↗
• MalfunctionDec 5, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE DETACHED PART WAS IMMEDIATELY REMOVED UPON DETECTED AND REPLACED THE VITRECTOMY PROBE.

  Patient problems: Eye Irritation

  MAUDE report 23729525 ↗
• MalfunctionDec 1, 2025Failure to Cut; Failure to Cut

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT PROBE WAS NOT CUTTING DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING WITH NEW PACK. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23677945 ↗
• MalfunctionNov 27, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT PROBE COULD NOT CUT DURING 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 23663936 ↗
• MalfunctionNov 27, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A PHYSICIAN REPORTED THAT THE PROBE SHOWED NO CUTTING AND LOW VACUUM UPON INSERTION INTO THE EYE, AUDIBLE VACUUM AND CUT SOUNDS WERE PRESENT, BUT PNEUMATIC CUT SOUND WAS WEAK DURING CATARACT AND VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED BY PACK AND PROBE REPLACEMENT. THERE WAS NO PATIENT IMPACT NEW INFORMATION RECEIVED STATING THAT THE ISSUE WAS RELATED TO THE PROBE, NO ISSUE REPORTED FOR THE PACK AND CASSETTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663289 ↗
• MalfunctionNov 25, 2025Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED THAT CUTTER IN PACK WAS SLUGGISH NOT WORKING PROPERLY AT UNKNOWN TIMING OF VITRECTOMY SURGERY. THE PROCEDURE COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23645829 ↗
• MalfunctionNov 25, 2025Failure to Cut; Suction Failure; Failure to Cut; Suction Failure

  A PHYSICIAN REPORTED THAT CUTTER FROM NEWLY OPENED PAK WAS NOT WORKING AS IT WAS NEITHER CUTTING NOR ASPIRATING. THE PROCEDURE TYPE WAS RETINAL DETACHMENT SURGERY AND WAS COMPLETED BY REPLACING WITH ANOTHER PAK. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23642797 ↗
• MalfunctionNov 19, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE PROBE COULD NOT SUCK AND CUT PROPERLY DURING VITRECTOMY SURGERY. 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 23592083 ↗
• MalfunctionNov 18, 2025Failure to Cut; Failure to Cut

  THE PHYSICIAN REPORTED THAT CUTTER WAS NOT CUTTING EFFICIENTLY DURING THE SURGERY. THE SURGERY WAS COMPLETED AFTER CHANGING THE PACK. THE PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23579499 ↗
• MalfunctionNov 12, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE COULD NOT CUT BEFORE 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 23530020 ↗
• MalfunctionNov 6, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THE VITRECTOR STOPPED CUTTING DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23484414 ↗
• MalfunctionOct 30, 2025Defective Device

  CUTTER IN PACK SLUGGISH - NOT WORKING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424776 ↗