BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIA360 SURGICAL SYSTEM

    MDR report key: 23241310 · Received October 7, 2025

    Report

    Report Number
    1000125279-2025-00033
    Event Type
    Injury
    Date Received
    October 7, 2025
    Report Date
    October 6, 2025
    Manufacturer
    NEW WORLD MEDICAL, INC.
    Product Code
    HMZ
    PMA / PMN Number
    K243503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE IFU FOR THE REPORTED PRODUCT MODEL WAS REVIEWED AND CONFIRMED TO INCLUDE DESCEMET'S MEMBRANE TEAR OR DETACHMENT AS A KNOWN COMPLICATION. THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED, AS NO SPECIFIC SERIAL OR LOT INFORMATION WAS AVAILABLE. THE PRODUCT WAS MANUFACTURED, TESTED, AND RELEASED IN ACCORDANCE WITH VALIDATED PROCEDURES. AS THE DEVICE IS NOT AVAILABLE FOR RETURN, NO DEVICE MALFUNCTION COULD BE CONFIRMED.

    Description of Event or Problem · 0

    DESCEMET DETACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2509273 VIA360 SURGICAL SYSTEM INFUSION PUMP HMZ NEW WORLD MEDICAL, INC. VIA360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention