Constellation, Ultravit, TotalPlus, EdgePlus 8065751765Recalls & reported problems

Summary

The FDA's MAUDE database contains 208 adverse event reports that list this exact device (DI 00380657517657), received between Apr 6, 2021 and Sep 30, 2026 — classified as 3 injuries, 205 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (127 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 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 208 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Use of Device Problem

  A non-healthcare professional reported that cutter failed to operate during retinal surgery. The surgery was completed on the same day, after replacing the product with another one. There was no information about patient impact.Additional information was requested and non-received till date.

  Patient problems: Insufficient Information

  MAUDE report 50948318 ↗
• MalfunctionAug 21, 2026Failure to Cut

  A customer reported that there was a malfunction with cutter (vitrectomy probe) during a vitrectomy surgery. The aspiration function was good. To avoid any delay to the patient, a new cutter from the same lot was immediately opened and used. The replacement cutter functioned properly, and the surgery was completed successfully without further issues. There was no information about any patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50373400 ↗
• MalfunctionAug 14, 2026Failure to Cut

  Patient problems: Insufficient Information

  MAUDE report 50250758 ↗
• MalfunctionAug 11, 2026Failure to Cut

  A physician reported that cutting function of the cutter was not functioning, only aspiration function remained functional during vitreoretinal surgery. The surgery was completed on the same day, after replacing the cutter with another one. There was no information about patient impact. Additional information was requested and non-received till date.

  Patient problems: Insufficient Information

  MAUDE report 50211327 ↗
• MalfunctionJan 28, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT 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 24198789 ↗
• MalfunctionJan 27, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT 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 24187936 ↗
• MalfunctionJan 26, 2026Failure to Cut

  A NURSE REPORTED THAT THE CUTTER DID NOT CUT AT UNKNOWN TIMING OF VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PACK WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS REQUESTION BUT NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176008 ↗
• MalfunctionDec 29, 2025Leak/Splash; Suction Problem; Leak/Splash; Suction Problem

  A PHYSICIAN REPORTED THAT THE BASE OF THE VITRECTOMY PROBE HEAD LEAKED AND IT WAS SUSPECTED THAT THE ASPIRATION LINE LEAKED, SUCTION NEGATIVE PRESSURE REDUCED DURING VITRECTOMY SURGERY. IT WAS NORMAL AFTER REPLACING WITH A NEW ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23904875 ↗
• MalfunctionDec 26, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE DID NOT CUT AND ASPIRATE DURING 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 23895886 ↗
• MalfunctionDec 25, 2025Suction Problem; Air/Gas in Device; Suction Problem; Air/Gas in Device

  A PHYSICIAN REPORTED THAT PROBE HAD NO ASPIRATION AND SPIT BUBBLES 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 23892343 ↗
• MalfunctionDec 24, 2025Failure to Cut; Failure to Cut

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT VITRECTOMY PROBE COULD NOT CUT OCCURRED 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 23886280 ↗
• MalfunctionDec 24, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE COULD NOT CUT, NOR ASPIRATE 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 23886278 ↗
• MalfunctionDec 22, 2025Failure to Cut; Suction Failure; Failure to Cut; Suction Failure

  A PHYSICIAN REPORTED THAT THE PROBE VIT COULD NOT CUT AND COULD NOT ASPIRATE DURING VITRECTOMY SURGERY. THE SURGERY WAS PROCESSED AFTER NEW PRODUCT REPLACEMENT. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874250 ↗
• MalfunctionDec 2, 2025Failure to Cut; Failure to Cut

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT PROBE ONLY ASPIRATES THE VITREOUS HUMOR BUT DID NOT CUT DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE CASSETTE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23690015 ↗
• MalfunctionNov 27, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT POOR CUTTING AND ASPIRATION WAS GOOD DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACEMENT OF PACK. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23664027 ↗
• MalfunctionNov 26, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  AN OPHTHALMIC SURGEON REPORTED THAT PROBE WAS NOT CUTTING AND ASPIRATING DURING COMBINED DIABETIC TRACTIONAL DETACHMENT SURGERY. THE SURGERY WAS COMPLETED BY REPLACING ANOTHER PACK. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23653728 ↗
• MalfunctionNov 24, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A PHYSICIAN REPORTED THAT THE PROBE COULD NOT CUT OR ASPIRATE DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE PRODUCT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23628519 ↗
• MalfunctionNov 21, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE COULD NOT CUT OR ASPIRATE DURING VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT THE PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23615561 ↗
• MalfunctionNov 19, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT PROBE HAD POOR CUTTING PERFORMANCE 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 23595215 ↗
• MalfunctionNov 18, 2025Suction Problem; Suction Problem

  THE PHYSICIAN REPORTED THAT PROBE HAD NO ASPIRATION DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACEMENT WITH NEW PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23579500 ↗
• MalfunctionNov 18, 2025Suction Problem; Suction Problem

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

  Patient problems: Insufficient Information

  MAUDE report 23579250 ↗
• MalfunctionNov 12, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A PHYSICIAN REPORTED THAT THE PROBE STOPPED CUTTING HALFWAY AND THE ASPIRATION WAS WEAK 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 23530572 ↗
• MalfunctionOct 23, 2025Failure to Cut; Failure to Cut

  ADDITIONAL INFORMATION RECEIVED THE EVENT OCCURRED DURING CATARACT AND VITRECTOMY COMBINATION SURGERY THERE WAS NO PATIENT IMPACT. LALITHAS A CUSTOMER REPORTED THAT NO GUILLOTINE MOVEMENT AT AN UNKNOWN TIMING. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23366273 ↗
• MalfunctionOct 17, 2025Suction Problem; Infusion or Flow Problem; Suction Problem; Infusion or Flow Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT IRRIGATION AND ASPIRATION WERE NOT POSSIBLE DURING THE SURGERY. THE PROCEDURAL TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23320818 ↗
• MalfunctionSep 5, 2025Failure to Cut; Failure to Cut

  THE PHYSICIAN REPORTED THAT THE PROBE SUDDENLY COULD NOT CUT DURING THE VITRECTOMY SURGERY AND ONLY ASPIRATION WAS AVAILABLE. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22976368 ↗