BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIOLI IOL DELIVERY SYSTEM

    MDR report key: 17365434 · Received July 20, 2023

    Report

    Report Number
    1000635309-2023-00001
    Event Type
    Injury
    Date Received
    July 20, 2023
    Date of Event
    June 26, 2023
    Report Date
    July 20, 2023
    Manufacturer
    AST PRODUCTS, INC.
    Product Code
    MSS
    UDI-DI
    10814899027027
    PMA / PMN Number
    K142056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    REPORTER STATED ICL LENS WAS TORN ON INSERTION. DOCTOR NOTED LARGE TEAR IN ICL AFTER IMPLANT WITH THE INJECTOR. THE LENS CAPSULE WAS VIOLATED AND THE SURGEON ENDED UP DOING A REFRACTIVE LENS EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35113 LIOLI IOL DELIVERY SYSTEM LIOLI IOL DELIVERY SYSTEM MSS AST PRODUCTS, INC. LIOLI-24 FCK1701 10814899027027

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention