BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIA360 SURGICAL SYSTEM

    MDR report key: 23779959 · Received December 11, 2025

    Report

    Report Number
    1000125279-2025-00047
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    November 14, 2025
    Report Date
    December 10, 2025
    Manufacturer
    NEW WORLD MEDICAL, INC.
    Product Code
    HMZ
    UDI-DI
    00892064002362
    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 HYPHEMA AS A KNOWN COMPLICATION. ADDITIONALLY, THE IFU STATES THAT THE SURGEON SHOULD MONITOR AND MANAGE INTRAOCULAR PRESSURE POSTOPERATIVELY IF IT IS NOT ADEQUATELY MAINTAINED. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT WAS REVIEWED, AND NO ISSUES WERE IDENTIFIED. 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

    A SURGEON USED A VIA360 FROM MY TRUNK STOCK FOR EVALUATION. THE DEVICE WAS USED WITHOUT INCIDENT OR COMPLICATION. I POSTED IN SALESFORCE THAT WHEN I CHECKED IN TO FOLLOW UP WITH THE SURGEON POST OP DAY 1, THE SURGEON INFORMED ME THAT THE PATIENTS IOP WAS ELEVATED OFF GLAUCOMA MEDS, AND THAT A MICROHYPHEMA WAS VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2555233 VIA360 SURGICAL SYSTEM INFUSION PUMP HMZ NEW WORLD MEDICAL, INC. VIA 360 H2125 00892064002362

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention