BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SION SURGICAL INSTRUMENT

    MDR report key: 25124721 · Received May 8, 2026

    Report

    Report Number
    3010363671-2026-00005
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    April 9, 2026
    Report Date
    May 8, 2026
    Manufacturer
    SIGHT SCIENCES INC
    Product Code
    HMZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PRIOR TO INITIATING THE PROCEDURE, THE SURGEON OBSERVED THAT THE FOOT OF THE SION DEVICE WAS MISSING FROM THE INSTRUMENT. THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT'S EYE. EVEN THOUGH THE BROKEN FOOT OCCURRED BEFORE THE POTENTIAL PROCEDURE, A BROKEN OR MISSING FOOT COULD CAUSE A SERIOUS INJURY IF IT WERE TO HAVE BEEN USED OR IF IT BROKE IN THE PATIENT'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221958 SION SURGICAL INSTRUMENT SION SURGICAL INSTRUMENT HMZ SIGHT SCIENCES INC F25G27-02

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown