Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751618Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00380657516186), received between Aug 11, 2021 and Sep 26, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (4 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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-2674-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2024Suction Problem; Suction Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE ASPIRATION WAS POOR DURING VITRECTOMY-RETINAL (VIT-RET) SURGERY. THEY REMOVED THE ENTIRE PAK FROM THE STERILE FIELD, REPLACED WITH NEW AND COMPLETED THE PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20308923 ↗
• MalfunctionMar 1, 2024Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THERE WAS A MALFUNCTION WITH CUTTER OPERATION; CUTTING DID NOT OCCUR AND TISSUE WAS NOT CUT PROPERLY DURING VITRECTOMY SURGERY. THE SURGERY WAS CONCLUDED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE CONDITION OF ASPIRATION WAS UNKNOWN. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18818089 ↗
• MalfunctionJan 18, 2024Infusion or Flow Problem; Infusion or Flow Problem

  A NURSE REPORTED THAT THE WATER WAS NOT COMING OUT OF THE INFUSION PUMP BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 18533387 ↗
• MalfunctionJan 8, 2024No Flow; No Flow

  A NURSE REPORTED THAT NO AIR FLOW IN FLUID AND AIR EXCHANGE MODE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY REPLACING WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18461806 ↗
• MalfunctionSep 7, 2022Fluid/Blood Leak; Device Displays Incorrect Message; Fluid/Blood Leak; Device Displays Incorrect Message

  A CUSTOMER REPORTED THE CASSETTE WAS LEAKING. THE TIMING AND THE TYPE OF THE SURGERY IS UNKNOWN. THERE IS NO REPORT OF A PATIENT HARM. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REPRESENTATIVE WHO STATED DURING SETUP THE TECHNICIAN NOTED MESSAGE ON THE CONSOLE STATING NO BALANCE SALT SOLUTION (BSS) AND ALSO DISCOVERED THE BSS LEAKED ON THE FLOOR HOWEVER THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15370300 ↗
• MalfunctionSep 7, 2022Fluid/Blood Leak; Device Displays Incorrect Message; Fluid/Blood Leak; Device Displays Incorrect Message

  A CUSTOMER REPORTED THE CASSETTE WAS LEAKING. THE TIMING AND THE TYPE OF THE SURGERY IS UNKNOWN. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REPRESENTATIVE THAT TECHNICIAN NOTED THE MESSAGE ON THE CONSOLE STATING NO BALANCED SALT SOLUTION (BSS) DURING CALIBRATION. A NEW FLUIDIC MANAGEMENT SYSTEM (FMS) WAS USED TO COMPLETE THE SET UP FOR PROCEDURE. THERE WAS NO PATIENT HARM. SAMPLE WAS AVAILABLE FOR RETURN. NO FURTHER DETAILS TO PROVIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15370001 ↗
• MalfunctionAug 25, 2022Fluid/Blood Leak; Failure to Calibrate; Fluid/Blood Leak; Failure to Calibrate

  A CUSTOMER REPORTED THE CASSETTE WAS LEAKING AND NEVER PRIMED DURING CALIBRATION. THE PRODUCT WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THE PRODUCT WAS NOT AVAILABLE FOR RETURN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15294658 ↗
• MalfunctionJul 7, 2022Failure to Cut; Failure to Cut

  A HEALTH PROFESSIONAL REPORTED THAT MULTIPLE VITRECTOMY CUTTERS WERE CUTTING INTERMITTENTLY AND SOMETIMES THERE WAS NO CUTTING. IT WAS NOTED THAT THE PROBLEM WAS WITH THE OPHTHALMIC CONSOLE PNEUMATIC ASSEMBLY PANEL. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14946892 ↗
• MalfunctionJul 7, 2022Failure to Cut; Failure to Cut

  A HEALTH PROFESSIONAL REPORTED THAT MULTIPLE VITRECTOMY CUTTERS WERE CUTTING INTERMITTENTLY AND SOMETIMES THERE WAS NO CUTTING. IT WAS NOTED THAT THE PROBLEM WAS WITH THE OPHTHALMIC CONSOLE PNEUMATIC ASSEMBLY PANEL. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14946845 ↗
• MalfunctionJul 7, 2022Failure to Cut; Failure to Cut

  A HEALTH PROFESSIONAL REPORTED THAT MULTIPLE VITRECTOMY CUTTERS WERE CUTTING INTERMITTENTLY AND SOMETIMES THERE WAS NO CUTTING. IT WAS NOTED THAT THE PROBLEM WAS WITH THE OPHTHALMIC CONSOLE PNEUMATIC ASSEMBLY PANEL. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14946826 ↗
• MalfunctionMay 24, 2022No Flow; No Flow

  A NURSE REPORTED BALANCED SALT SOLUTION (BSS) WAS NOT FLEW IN THE INFUSION LINE DURING VITRECTOMY PROCEDURE. THE PRODUCT WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14486636 ↗
• MalfunctionMay 16, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A CUSTOMER REPORTED A CASSETTE WAS LEAKING. THE TIMING OF THE EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE COMPANY REPRESENTATIVE WHO STATED THAT THE CASSETTE WAS LEAKING FROM THE BACK DURING PRIMING. THE PRODUCT WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INVOLVEMENT. THE SAMPLE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407485 ↗
• MalfunctionAug 11, 2021Infusion or Flow Problem; Infusion or Flow Problem

  A NURSE REPORTED THE SURGEON TRIED TO PUT AIR INTO THE EYE USING THE FLUID/AIR EXCHANGE FUNCTION, BUT NO AIR CAME OUT FROM THE INFUSION CANNULA DURING A VITRECTOMY PROCEDURE. THE PRODUCT WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306050 ↗