BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIA360 SURGICAL SYSTEM

    MDR report key: 23780230 · Received December 11, 2025

    Report

    Report Number
    1000125279-2025-00048
    Event Type
    Injury
    Date Received
    December 11, 2025
    Report Date
    December 10, 2025
    Manufacturer
    NEW WORLD MEDICAL, INC.
    Product Code
    HMZ
    PMA / PMN Number
    K243503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    MET DR (B)(6) AND HE'S STILL CONCERNED WITH THE DESCEMET TEARS HE'S HAD WITH VIA360 AND HAS GONE BACK TO USING SOME OMNI EDGE. AGAIN, DISCUSSED DELIVERING LESS OVD IF HE'S CONCERNED. RECOMMENDED ONLY DELIVERY ON PROGRESSIONS AND NOT ON RETRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2718407 VIA360 SURGICAL SYSTEM INFUSION PUMP HMZ NEW WORLD MEDICAL, INC. VIA 360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention