Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751617Recalls & reported problems

Summary

The FDA's MAUDE database contains 398 adverse event reports that list this exact device (DI 00380657516179), received between Mar 24, 2021 and Sep 30, 2026 — classified as 6 injuries, 392 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (161 reports).

2 FDA recall records name this device's identifier, 2 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 ↗

2. Jul 15, 2024Open, Classified

   Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

   Z-2673-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 398 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Suction Problem; Failure to Cut

  A nurse reported that cutter failed to cut and aspirate during the vitrectomy surgery. The surgery was completed by replacing the cutter. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943551 ↗
• MalfunctionSep 30, 2026Break

  A healthcare professional reported that tip of the vitrectomy probe broke off inside the eye during surgery. The surgery type was unknown. The broken tip was successfully removed from the eye without further complications. The surgery completions details were unknown. There was no information about patient impact.Additional information was requested and non-received till date.

  Patient problems: Insufficient Information

  MAUDE report 50943104 ↗
• MalfunctionSep 28, 2026Failure to Cut

  A nurse reported that the cutter was not cut 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 50915635 ↗
• MalfunctionAug 17, 2026Use of Device Problem

  A health care professional reported that the cutter (vitrectomy probe) was not performing during vitrectomy surgery. The surgery was completed on same day. There was no information about any patient impact.Additional information has been requested but none received till date.

  Patient problems: Insufficient Information

  MAUDE report 50271405 ↗
• MalfunctionAug 12, 2026Failure to Cut

  Patient problems: Insufficient Information

  MAUDE report 50224294 ↗
• MalfunctionAug 12, 2026Failure to Cut

  Patient problems: Insufficient Information

  MAUDE report 50224293 ↗
• MalfunctionAug 12, 2026Failure to Cut

  Patient problems: Insufficient Information

  MAUDE report 50224287 ↗
• MalfunctionAug 11, 2026Failure to Cut

  Patient problems: Insufficient Information

  MAUDE report 50206363 ↗
• MalfunctionJan 23, 2026Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED THAT PROBE GOT BEND AND THEN DETACHED DURING SURGERY. PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON SAME DAY. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24159071 ↗
• MalfunctionJan 12, 2026Fluid/Blood Leak

  A PHARMACIST REPORTED THAT THE VALVED TROCARS BEGAN TO LEAK DURING CALIBRATION OF VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24033764 ↗
• MalfunctionJan 8, 2026Noise, Audible; Air/Gas in Device

  A PHYSICIAN REPORTED THAT A STRANGE SOUND WAS HEARD FROM THE CASSETTE AND ALSO, AIR GOT INTO THE CASSETTE A LOT 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 24000517 ↗
• MalfunctionJan 7, 2026Suction Problem; Failure to Cut

  A NURSE REPORTED THAT THE CUTTER HAD POOR ACTUATION AND ASPIRATION OF THE CUTTER COULD NOT BE PERFORMED 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 23989890 ↗
• MalfunctionJan 2, 2026Disconnection

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE VITRECTOMY SURGERY THE TIP OF THE VITRECTOR WAS DETACHED FROM THE VITRECTOR. THE SURGERY WAS COMPLETED ON THE SAME DAY BUT IT WAS UNKNOWN HOW IT WAS COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23942551 ↗
• MalfunctionDec 29, 2025Break; Failure to Cut; Break; Failure to Cut

  AN OPHTHALMIC SURGEON REPORTED THAT CUTTER WAS NOT WORKING WELL (CUTTER WITH 7500 CUTS PER MINUTE WAS NOT WORKING WELL AND HE REDUCED IT TO 5000 CUTS PER MINUTE) AND CUTTER BROKE INSIDE THE TROCAR DURING SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED ON SAME DAY. PROCEDURE TYPE WAS UNKNOWN AND THERE WAS NO INFORMATION ABOUT THE PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23904928 ↗
• MalfunctionDec 26, 2025Failure to Cut; Ambient Noise Problem; Air/Gas in Device; Failure to Cut; Ambient Noise Problem; Air/Gas in Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT CUTTING HAD SOUND AND CREATED A LOT OF BUBBLE AND EVENTUALLY GOT STUCK AT AN UNKNOWN TIMING OF SURGERY. THE PROCEDURAL TYPE WAS UNKNOWN. THE SURGERY COMPLETION AND REPLACEMENT DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23894785 ↗
• MalfunctionDec 24, 2025Suction Problem; Suction Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT PROBE HAD INSUFFICIENT ASPIRATION EFFICIENCY BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING WITH NEW PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887519 ↗
• MalfunctionDec 15, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT PROBE HAD NO CUTTING DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY; HOWEVER, THE METHOD OF COMPLETION WAS UNKNOWN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803802 ↗
• MalfunctionDec 15, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A NURSE REPORTED THAT THE VITRECTOME STOPPED CUTTING, THE VITRECTOMY PORT WAS BLOCKED BY A JAMMED BLADE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23801888 ↗
• MalfunctionDec 11, 2025Disconnection; Ambient Noise Problem; Disconnection; Ambient Noise Problem

  A NURSE REPORTED THAT EXCESSIVE VIBRATIONS OF THE VITRECTOMY AND GRADUAL LOOSENING OF THE VITRECTOMY TIP DURING VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED ON SAME DAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777717 ↗
• MalfunctionDec 4, 2025Failure to Cut; Failure to Cut

  A PHARMACIST REPORTED THAT PROBE DID NOT PERFORM CUTTING AND ASPIRATION WAS NORMAL DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING WITH NEW PROBE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23715143 ↗
• MalfunctionDec 4, 2025Failure to Cut; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT CUTTER HEAD STOPPED WORKING DURING VITRECTOMY SURGERY. THE NEW PRODUCT WAS REPLACED TO COMPLETE THE SURGERY. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED THAT THE CUTTING WAS NOT WORKING. THE ASPIRATION AND ACTUATION CONDITION WAS UNKNOWN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714821 ↗
• MalfunctionNov 25, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE HAD POOR CUTTING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645072 ↗
• MalfunctionNov 24, 2025Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT THE VITRECTOMY PROBE COULD NOT CUT THE VITREOUS DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH A NEW VITRECTOMY PROBE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23628528 ↗
• MalfunctionNov 11, 2025Failure to Cut; Failure to Cut

  A HEALTH CARE PROFESSIONAL REPORTED THAT IN A PARS PLANA VITRECTOMY (PPV) SURGERY, THE CUTTER PROBES WERE NOT CUTTING. NURSE CHANGED CUTTER PROBE TWICE UNTIL THE PROBE COULD CUT PROPERLY AND FINISHED CASE IN THAT DAY. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520633 ↗
• MalfunctionNov 7, 2025Leak/Splash; Leak/Splash

  A PHYSICIAN REPORTED THAT CASSETTE LEAKED WATER BEFORE 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 23497595 ↗