Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752451Recalls & reported problems

Summary

The FDA's MAUDE database contains 258 adverse event reports that list this exact device (DI 00380657524518), received between Mar 4, 2021 and Sep 30, 2026 — classified as 14 injuries, 244 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (149 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-2108-2025 · 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-2679-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 258 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Use of Device Problem

  A health care professional reported that cutter stopped working during macula surgery. The surgery was completed on the same day after replacing it with another product. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943431 ↗
• MalfunctionSep 29, 2026Failure to Cut

  A physician reported that during cataract and vitrectomy combination surgery, the vitrectomy probe did not actuate. Reducing the speed from 10,000 cuts per minute to 5,000 cuts per minute did not improve the situation. The procedure was completed on same day by replacing with same product. There was patient contact with suspect product but no impact to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934803 ↗
• MalfunctionSep 29, 2026Use of Device Problem

  A healthcare professional reported that cutter stop when reaching peripheral of retina at certain angle 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 50928048 ↗
• MalfunctionSep 25, 2026Fluid/Blood Leak

  A healthcare professional reported that during a vitreo-retinal surgery, a large amount of air leakage from the trocar valve was observed in Fluid-Air Exchange mode, making it impossible to continue the surgery. The surgery was completed on the same day after the product was replaced with another one. There was no impact on the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898917 ↗
• MalfunctionSep 24, 2026Failure to Cut

  A health care professional reported that vitrector stopped cutting during vitrectomy surgery. The procedure 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 50879821 ↗
• MalfunctionSep 23, 2026Use of Device Problem

  A physician reported that the failure of cutter occurred at unknown timing of surgery. The procedure type was unknown. The surgery was completed on the same day after replacing the product with another one. There was no patient contact with the product.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864796 ↗
• MalfunctionAug 9, 2026Failure to Cut

  A physician reported that cutter failure (probably insufficient rotation) during calibration. The procedure type was unknown. The surgery completion details were unknown. There was no patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50189044 ↗
• MalfunctionMay 22, 2026Suction Problem; Failure to Cut

  A NURSE REPORTED THAT THE CUTTER (VITRECTOMY PROBE) WAS DEFECTIVE AS THERE WAS NO CUTTING AND SUCTION FUNCTION BEFORE VITRECTOMY SURGERY. THE REPLACEMENT WAS DONE WITH NEW PRODUCT, AND COMPLETED SURGERY WITHOUT ANY IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25252187 ↗
• MalfunctionApr 28, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT THE ACTUATION FAILURE OF THE CUTTER DURING CATARACT/VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE SAME PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25012362 ↗
• MalfunctionApr 23, 2026Failure to Cut

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT PROBE STOP CUTTING, EVEN WITH LOWER CUT RATE DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ONE THE SAME DAY AFTER REPLACING WITH ANOTHER PRODUCT. THERE WAS PATIENT CONTACT BUT NO ADVERSE EFFECTS FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24962668 ↗
• MalfunctionApr 8, 2026Failure to Prime; Obstruction of Flow

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT TWO FLUID MANAGEMENT SYSTEMS FAILED THE PURGE PROCESS AS THE HOSES WERE CLOGGED OR STUCK BEFORE VITRECTOMY SURGERY. IT WAS UNKNOWN HOW THE SURGERY WAS COMPLETED. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION WAS REQUESTED AND NON-RECEIVED TILL DATE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24815935 ↗
• MalfunctionMar 20, 2026Failure to Cut

  THE HEALTHCARE PROFESSIONAL REPORTED THAT VITRECTOR DID NOT CUT BEFORE VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED ON SAME DAY BUT DETAILS WERE UNKNOWN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647331 ↗
• MalfunctionMar 9, 2026Failure to Cut

  A CUSTOMER REPORTED THAT THE PROBE HAD FAILED IN ITS NORMAL CUTTING FUNCTION AT AN UNKNOWN TIME. THE SURGICAL DETAILS AND PROCEDURE TYPE WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24542293 ↗
• MalfunctionMar 6, 2026Failure to Cut

  A NONHEALTHCARE PROFESSIONAL REPORTED THAT VITRECTOMY PROBE WAS EXPERIENCING FAILURE IN ITS NORMAL CUTTING FUNCTION DURING VITRECTOMY SURGERY. THE SURGERY COMPLETION 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 24530762 ↗
• MalfunctionMar 5, 2026Failure to Cut

  A CUSTOMER REPORTED VIA THE HEALTH AUTHORITY THAT THE PROBE HAD FAILED TO CUT DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER THE PRODUCT WAS REPLACED WITH ANOTHER ONE. THERE WAS NO INFORMATION AVAILABLE REGARDING PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24516234 ↗
• MalfunctionFeb 19, 2026Failure to Cut

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PROBE HAD POOR CUTTING PERFORMANCE. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. RESPONSE AWAITED.

  Patient problems: Insufficient Information

  MAUDE report 24386253 ↗
• MalfunctionFeb 12, 2026Failure to Cut

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AT THE MOMENT THE PHYSICIAN USED THE PROBE TO CUT THE VITREOUS, THE PROBE MALFUNCTIONED. IT WAS ONLY ASPIRATING AND NOT PERFORMING THE CUTTING FUNCTION DURING 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 24324099 ↗
• MalfunctionFeb 12, 2026Failure to Cut

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AT THE MOMENT THE PHYSICIAN USED THE PROBE TO CUT THE VITREOUS, THE PROBE MALFUNCTIONED. IT WAS ONLY ASPIRATING AND NOT PERFORMING THE CUTTING FUNCTION DURING 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 24324097 ↗
• MalfunctionFeb 9, 2026Failure to Cut

  A CUSTOMER REPORTED VITRECTOMY PROBE FAILED TO CUT PROPERLY DURING VITRECTOMY SURGERY. TO CONTINUE THE SURGERY, THE DOCTOR SUBSTITUTED A VITRECTOMY PROBE FROM A DIFFERENT PAK. THE CONDITION OF ASPIRATION AND ACTUATION WAS UNKNOWN. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289360 ↗
• MalfunctionFeb 8, 2026Suction Problem; Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE COULD NOT CUT TISSUE AND ASPIRATION EFFICIENCY WAS LOW 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 24288290 ↗
• MalfunctionFeb 6, 2026Fluid/Blood Leak; Leak/Splash; Solder Joint Fracture; Air/Gas in Device

  A NURSE REPORTED THAT THERE WAS WATER LEAKING OF CASSETTE AND AIV (AUTO INFUSION VALVE) HAD AIR LEAKAGE 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 24278612 ↗
• MalfunctionFeb 6, 2026Failure to Cut

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT THE VITRECTOMY PROBE COULD NOT CUT BEFORE PEELING EPI RETINAL MEMBRANE (ERM) SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING WITH PROBE FROM ANOTHER PAK. THERE WAS NO PATIENT CONTACT WITH SUSPECT PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24276057 ↗
• MalfunctionFeb 6, 2026Failure to Cut

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT THE VITRECTOMY PROBE COULD NOT CUT BEFORE PEELING EPI RETINAL MEMBRANE (ERM) SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING WITH PROBE FROM ANOTHER PAK. THERE WAS NO PATIENT CONTACT WITH SUSPECT PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24276052 ↗
• MalfunctionFeb 5, 2026Failure to Cut

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE VITRECTOMY PROBE FAILED TO CUT PROPERLY DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING A VITRECTOMY PROBE FROM A DIFFERENT PAK. THIS MADE THINGS DIFFICULT FOR THE DOCTOR BUT COULD NOT NEGATIVELY IMPACT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275230 ↗
• MalfunctionFeb 5, 2026Failure to Cut

  A HEALTH CARE PROFESSIONAL REPORTED THAT CUTTING PROBE BECAME UNABLE TO CUT DURING THE VITRECTOMY SURGERY AND COMPLETELY STOPPED. IT WAS INITIALLY SET TO FIVE THOUSAND CUTS AND USED FROM THE START, BUT AFTER WORKING WITHOUT ISSUES FOR TWO TO THREE MINUTES, IT STOPPED CUTTING. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO CONTACT WITH THE PATIENT AND NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24265975 ↗