BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL VISC KIT VISCOELASTIC SYSTEM NEEDLE KIT

    MDR report key: 24859592 · Received April 13, 2026

    Report

    Report Number
    MW5186743
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    April 7, 2026
    Report Date
    April 8, 2026
    Manufacturer
    BAUSCH & LOMB/ LIFECORE BIOMEDICAL, LLC.
    Product Code
    LZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ONE OF THE NURSES AT THE PAV (PROPORTIONAL ASSIST VENTILATION) BROUGHT BACK A TOTALVISC TO THE PHARMACY THAT THEY OPENED IN THE OPERATING ROOM. THEY DID NOT USE THIS PRODUCT BECAUSE THE NEEDLE HAD A DARK SPOT ON IT. THIS IS A BAUSCH & LOMB PRODUCT MANUFACTURED BY LIFECORE BIOMEDICAL. THE LOT IS 031181, AND EXPIRATION IS 10/31/2027.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928516 TOTAL VISC KIT VISCOELASTIC SYSTEM NEEDLE KIT AID, SURGICAL, VISCOELASTIC LZP BAUSCH & LOMB/ LIFECORE BIOMEDICAL, LLC. 031181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown