Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751767Recalls & reported problems

Summary

The FDA's MAUDE database contains 302 adverse event reports that list this exact device (DI 00380657517671), received between Mar 18, 2021 and Sep 29, 2026 — classified as 5 injuries, 297 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (113 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. 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-2109-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jul 15, 2024Class IIOpen, 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-2675-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 302 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Failure to Cut

  A physician reported that vitrectomy probe was unable to work normally 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.Additional information received that the issue was the vitrectomy probe had no cutting and the aspiration was normal.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927821 ↗
• MalfunctionSep 25, 2026Improper Flow or Infusion

  A physician reported that the fluid continuously flowed from the tubing with no air output; after repeated attempts, only a small amount of air was delivered during the air-fluid exchange for the vitrectomy surgery. The surgery was completed on same day after replacing the product with new one. There was no impact on the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896950 ↗
• MalfunctionAug 17, 2026Failure to Cut

  A Physician reported that when cutting the vitreous body during vitrectomy surgery, the vit probe cannot complete effective cutting and there is only aspiration. The surgery was completed on same day after replacing with a new one. The patient returned smoothly to the ward after completing the surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50269233 ↗
• MalfunctionFeb 16, 2026Material Separation; Suction Problem

  A CUSTOMER REPORTED THAT THE FAULTY (GLUED TOGETHER) PURGE HOSES, VACUUM DELIVERY COLLAPSED IN AN UNKNOWN TIMING OF VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BUT UNKNOWN HOW IT WAS COMPLETED. OTHER SURGERY DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT IMPACT TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24360502 ↗
• MalfunctionJan 3, 2026Leak/Splash

  A PHYSICIAN REPORTED THAT CASSETTE LEAKED WATER BEFORE 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 23952939 ↗
• MalfunctionDec 29, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE HAD NO ASPIRATION BEFORE VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO REPORTED INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23904137 ↗
• MalfunctionDec 28, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE NEEDLE IS BENT 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 23903669 ↗
• MalfunctionDec 26, 2025Material Separation; Material Separation

  A CUSTOMER REPORTED THAT THE TUBING CONNECTION COULD NOT BE PROPERLY ATTACHED (MATERIAL SEPARATION) DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23895037 ↗
• MalfunctionDec 25, 2025Suction Problem; Suction Problem

  A NURSE REPORTED THAT THE VITRECTOMY PROBE HAD NO ASPIRATION 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 23892331 ↗
• MalfunctionNov 25, 2025Suction Problem; Defective Device; Suction Problem; Defective Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT CUTTER PRIMED AND WHEN THE CUTTER WAS IN PLACE, THE CUTTER MOVED FORWARD AND BACK AND DID NOT VACUUM DURING THE CALIBRATION OF VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER CUTTER REPLACED WITH ANOTHER. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23642004 ↗
• MalfunctionNov 20, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A HEALTH CARE PROFESSIONAL REPORTED THAT CUTTER HAD POOR CUTTING AND ASPIRATION DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER CHANGING THE CASSETTE IN THE MIDDLE OF THE SURGERY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23602817 ↗
• MalfunctionNov 17, 2025Leak/Splash; Leak/Splash

  A PHYSICIAN REPORTED THAT THE CASSETTE LEAKAGE OCCURRED BEFORE 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 23566887 ↗
• MalfunctionNov 14, 2025Leak/Splash; Leak/Splash

  A HEALTH CARE PROFESSIONAL REPORTED THAT CASSETTE WAS LEAKING FROM THE GREEN PORT DURING VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER CASSETTE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23551307 ↗
• MalfunctionNov 7, 2025Leak/Splash; Leak/Splash

  A PHYSICIAN REPORTED THAT THE PACKAGING WAS INTACT DURING USE, AFTER PASSING THE INSPECTION, IT WAS FOUND THAT THE CASSETTE HAD LEAKAGE BEFORE VITRECTOMY SURGERY. A NEW ONE WAS PROMPTLY REPLACED, WHICH DID NOT AFFECT THE SURGICAL PROGRESS. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23494634 ↗
• MalfunctionNov 4, 2025Leak/Splash; Leak/Splash

  A PHYSICIAN REPORTED THAT THE CASSETTE LEAKED WATER 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 23463327 ↗
• MalfunctionNov 4, 2025Leak/Splash; Failure to Prime; Leak/Splash; Failure to Prime

  A PHYSICIAN REPORTED THAT CASSETTE WAS LEAKING AND DID NOT PASS TEST 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 23462680 ↗
• MalfunctionNov 3, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT CUTTER PROBE NOT 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 23460270 ↗
• MalfunctionOct 31, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT CUTTER WAS NOT CUTTING DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW CUTTER. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23433888 ↗
• MalfunctionOct 28, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THE CUTTER WAS INTERMITTENTLY CUTTING DURING PARS PLANA VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PACK WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23402197 ↗
• MalfunctionOct 24, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE CUTTING FUNCTION OF PROBE WAS POOR BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE CONDITION OF ASPIRATION WAS NORMAL. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376559 ↗
• MalfunctionOct 21, 2025Failure to Cut; Failure to Cut

  A CONSUMER REPORTED THAT THE VITRECTOMY PROBE DID NOT CUT DURING VITRECTOMY SURGERY. IT WAS UNKNOWN IF THE SURGERY WAS COMPLETED. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23345427 ↗
• MalfunctionSep 19, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE HAD POOR CUTTING PERFORMANCE DURING VITRECTOMY SURGERY. THE ASPIRATION WAS WORKING NORMALLY. 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 23093800 ↗
• MalfunctionSep 12, 2025Suction Problem; Suction Problem

  AN OTHER HEALTH CARE PROFESSIONAL REPORTED THAT VITRECTOMY PROBE STOPPED TO ASPIRATE A SOLUTION DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER OPENING THE SECOND PHACO EMULSIFICATION SET. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042334 ↗
• MalfunctionAug 25, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT ACTUATION ISSUE OF VITRECTOMY PROBE OCCURRED DURING CATARACT AND VITRECTOMY COMBINED SURGERY. THE CONDITION OF ASPIRATING 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 22886267 ↗
• MalfunctionAug 5, 2025Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE PART OF PROBE TIP BROKEN AND FELL INTO THE EYE DURING VITRECTOMY SURGERY. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22710983 ↗