BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SION SURGICAL INSTRUMENT

    MDR report key: 23550245 · Received November 13, 2025

    Report

    Report Number
    3010363671-2025-00015
    Event Type
    Injury
    Date Received
    November 13, 2025
    Date of Event
    October 15, 2025
    Report Date
    May 9, 2026
    Manufacturer
    SIGHT SCIENCES INC
    Product Code
    HMZ
    UDI-DI
    00858027006501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE PHYSICIAN REPORTED THAT DURING USE OF THE SION DEVICE, THE DISTAL TIP BROKE OFF WHILE THE DEVICE WAS IN THE ANTERIOR CHAMBER. THE BREAKAGE WAS NOTICED PRIOR TO STARTING THE PROCEDURE. THE BROKEN PIECE WAS REMOVED FROM THE ANTERIOR CHAMBER BY USING VISCOELASTIC TO PUSH IT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546848 SION SURGICAL INSTRUMENT SION SURGICAL INSTRUMENT HMZ SIGHT SCIENCES INC F25F01-01 00858027006501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention