BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIA360 SURGICAL SYSTEM

    MDR report key: 22179296 · Received June 10, 2025

    Report

    Report Number
    1000125279-2025-00020
    Event Type
    Injury
    Date Received
    June 10, 2025
    Report Date
    June 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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IFU FOR THE REPORTED PRODUCT MODEL WAS REVIEWED AND CONFIRMED TO INCLUDE IRIS INJURY AS A KNOWN COMPLICATION. 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

    ONE PATIENT EXPERIENCED IRIS PROLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2033150 VIA360 SURGICAL SYSTEM INFUSION PUMP HMZ NEW WORLD MEDICAL, INC. VIA360 B0525 00892064002362

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention