BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SION SURGICAL INSTRUMENT

    MDR report key: 24990356 · Received April 24, 2026

    Report

    Report Number
    3010363671-2026-00002
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    March 25, 2026
    Report Date
    March 25, 2026
    Manufacturer
    SIGHT SCIENCES INC
    Product Code
    HMZ
    UDI-DI
    00858027006501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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
    545137 SION SURGICAL INSTRUMENT SION SURGICAL INSTRUMENT HMZ SIGHT SCIENCES INC F25F22-01 00858027006501

    Patients

    Seq Age Sex Outcome Treatment
    1