BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIA360 SURGICAL SYSTEM

    MDR report key: 22710136 · Received August 4, 2025

    Report

    Report Number
    1000125279-2025-00027
    Event Type
    Injury
    Date Received
    August 4, 2025
    Date of Event
    July 14, 2025
    Report Date
    August 4, 2025
    Manufacturer
    NEW WORLD MEDICAL, INC.
    Product Code
    HMZ
    PMA / PMN Number
    K243503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS MANUFACTURED, TESTED, AND RELEASED IN ACCORDANCE WITH VALIDATED PROCEDURES. AS INDICATED BY CUSTOMER IN THE INITAL REPORT, THE DEVICE/USAGE OF THE DEVICE WAS NOT CONSIDERED AS THE DIRECT CAUSE OF THE CORNEAL TEAR. RATHER, THE PATIENT MOVING THEIR EYE CAUSED THE TIP OF THE DEVICE TO MAKE CONTACT WITH THE PERIPHERAL CORNEA.

    Description of Event or Problem · 0

    A SMALL, 1MM DESCEMET TEAR IN THE PERIPHERAL CORNEA OCCURRED AFTER THE COMPLETION OF THE INITIAL INFERIOR VISCODILATION WITH THE VIA 360' DEVICE. AS I REMOVED THE TIP FROM THE NASAL TRABECULAR MESHWORK THE PATIENT MOVED THEIR EYE TOWARD THE CENTER, WHICH CAUSED THE TIP OF THE DEVICE TO MAKE CONTACT WITH THE PERIPHERAL CORNEA. THE LOCATION WAS 7:00 AND FAR PERIPHERAL BY THE LIMBUS. THE TEAR DID NOT CONTRIBUTE TO ANY POOR VIEW DURING THE SURGERY NOR DID IT IMPEDED ME FROM PERFORMING THE SUPERIOR VISCODILATION AND GONIOTOMY . I LEFT A SMALL AIR BUBBLE IN THE ANTERIOR CHAMBER AT THE RESOLUTION OF THE CASE. ON POST OP DAY 1 THE TEAR WAS APPROXIMATED AND BY POST OP WEEK 1 THE TEAR WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2635713 VIA360 SURGICAL SYSTEM INFUSION PUMP HMZ NEW WORLD MEDICAL, INC. VIA360

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Unknown Required Intervention