Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752438Recalls & reported problems

Summary

The FDA's MAUDE database contains 203 adverse event reports that list this exact device (DI 00380657524389), received between Jun 9, 2021 and Sep 24, 2026 — classified as 5 injuries, 198 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (115 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-2677-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 203 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Failure to Cut

  A pharmacist reported that the cutter speed remained at two thousand five hundred cuts per min instead of the indicated ten thousand cut per minute. Restarting the cassette did not increase the cutting speed during retinal detachment procedure. The surgery was completed by replacing the cassette. There was no information about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50877493 ↗
• MalfunctionSep 24, 2026Failure to Cut

  A pharmacist reported that the cutter speed was limited to 2,500 cuts per minute, whereas the packaging indicated 10000 cuts per minute. It was impossible to increase the cutting rate during surgery. The procedure type was unknown. The surgery was completed on the same day after replacing the product with another one. There was no information about the patient impact. Additional information has been requested but is not available at the time of this report

  Patient problems: Insufficient Information

  MAUDE report 50877276 ↗
• MalfunctionAug 12, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50221638 ↗
• MalfunctionAug 12, 2026Disconnection; Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218760 ↗
• MalfunctionAug 11, 2026Disconnection; Ambient Noise Problem

  A physician reported that unusual movement and sound were felt in the handle and metal sleeve came loose and fell to the bottom during vitrectomy surgery. The surgery was completed on the same day, but it was unknown how it got completed. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50206354 ↗
• MalfunctionMar 5, 2026Failure to Cut

  A NURSE REPORTED THAT CUTTER HEAD DID NOT CUT DURING VITREORETINAL SURGERY. THE CUTTER INITIALLY WORKED BUT GRADUALLY THE PERFORMANCE DECREASED DURING 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 24516233 ↗
• MalfunctionMar 5, 2026Suction Problem; Failure to Cut

  A NURSE REPORTED THAT CUTTER DID NOT ASPIRATE, DID NOT CUT AND RELEASED BUBBLES FROM THE ASPIRATION TUBE BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY REPLACING THE CUTTER HEAD WITH A NEW ONE WHICH FUNCTIONED NORMALLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24516228 ↗
• MalfunctionMar 4, 2026Suction Problem; Failure to Cut; Air/Gas in Device

  A NURSE REPORTED THAT THE CUTTERS DID NOT ASPIRATE, DID NOT CUT, AND RELEASED BUBBLES BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY AFTER REPLACING THE CUTTER HEAD. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24511827 ↗
• MalfunctionFeb 18, 2026Break; Failure to Cut; Ambient Noise Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE CATHETER DID NOT CUT WHEN INSERTED, IT BEGAN TO MAKE STRANGE NOISE, AND METAL PART OF THE CATHETER DETACHED FROM THE VITRECTOR CONTROL DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED ON SAME DAY BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376168 ↗
• MalfunctionFeb 16, 2026Suction Problem; Defective Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT VITRECTOME DID NOT ASPIRATE, IN THE OTHER THERE WAS A FACTORY DEFECT IN THE VITRECTOME TUBES AT AN UNKNOWN TIMING FOR VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY REPLACING WITH NEW PAK. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343695 ↗
• MalfunctionJan 28, 2026Infusion or Flow Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT NO INFUSION DURING CATARACT AND VITRECTOMY COMBINED PROCEDURE. THE SURGERY WAS COMPLETED ON THE SAME DAY, AND IT WAS UNKNOWN HOW IT GOT COMPLETED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24198245 ↗
• MalfunctionJan 22, 2026Suction Problem; Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE COULD NOT CUT AND ASPIRATE 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 24142730 ↗
• MalfunctionJan 21, 2026Improper Flow or Infusion

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AIR VALVE WOULD NOT OPEN AND WOULD NOT DRAIN DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED ON SAME DAY AFTER REPLACEMENT OF PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24127869 ↗
• MalfunctionJan 20, 2026Infusion or Flow Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT NO INFUSION DURING CATARACT/VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT CONTACT.

  Patient problems: Insufficient Information

  MAUDE report 24112407 ↗
• MalfunctionJan 17, 2026Leak/Splash

  A PHYSICIAN REPORTED THAT THE LEAKAGE OCCURRED FROM THE BOTTOM OF CASSETTE BEFORE SURGERY. THE PROCEDURE TYPE AND OTHER SURGERY DETAILS WERE UNKNOWN. IT WAS UNKNOWN WHETHER THE SURGERY WAS COMPLETED OR NOT. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24105304 ↗
• MalfunctionJan 12, 2026Suction Problem; Failure to Cut

  A PHYSICIAN REPORTED THE ACTUATION OF THE CUTTER WAS STRANGE AND ASPIRATION OF CUTTER WAS ALSO POOR DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS PATIENT CONTACT WITH SUSPECT PRODUCT BUT NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24040160 ↗
• MalfunctionJan 9, 2026Suction Problem

  A NURSE REPORTED THAT CUTTER WAS MALFUNCTIONED, SUCTION WAS NOT WORKING BEFORE INTRAOCULAR LENS IMPLANTATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE PRODUCT. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24019243 ↗
• MalfunctionJan 5, 2026Suction Problem; Failure to Cut

  A NURSE REPORTED THAT THE CUTTING AND SUCTION ARE NOT POSSIBLE BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING WITH A NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23954668 ↗
• MalfunctionDec 29, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE PROBE DID NOT CUT, DURING CATARACT AND 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 23904563 ↗
• MalfunctionDec 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A PHYSICIAN REPORTED THAT TWO CONSECUTIVE LEAKS FROM THE CLOSURE VALVE FROM THE TROCAR CLOSURE VALVE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY AFTER REPLACING WITH A NEW PAK AND ONLY THE TROCAR WAS REPLACED. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23903980 ↗
• MalfunctionDec 15, 2025Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED THAT CUTTER WAS NO CUTTING DURING SURGERY. THE PROCEDURE TYPE AND COMPLETION DETAILS WERE UNKNOWN. THE PROBE VACUUM WAS NORMAL. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED STATING THAT THE EVENT OCCURRED DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED ON SAME DAY AFTER REPLACEMENT OF PAK. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23801054 ↗
• MalfunctionDec 14, 2025Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED THAT THE 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 IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23799336 ↗
• MalfunctionDec 9, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT CUTTING FAILURE OF THE CUTTER OCCURRED DURING 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 23760062 ↗
• MalfunctionDec 5, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT BEFORE VITRECTOMY SURGERY, THE VITRECTOMY CUTTER (PROBE) DID NOT CUT. THE ASPIRATION FUNCTION WAS NORMAL. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23726213 ↗
• MalfunctionDec 4, 2025Failure to Cut; Failure to Cut

  AN OPHTHALMOLOGIST REPORTED THAT PROBE STOPPED CUTTING AND ONLY ABLE TO ASPIRATE DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY REPLACING THE CASSETTE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23712731 ↗