BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIOLI IOL DELIVERY SYSTEM

    MDR report key: 24895018 · Received April 16, 2026

    Report

    Report Number
    1000635309-2026-00002
    Event Type
    Injury
    Date Received
    April 16, 2026
    Report Date
    April 16, 2026
    Manufacturer
    AST PRODUCTS, INC.
    Product Code
    MSS
    PMA / PMN Number
    K142056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH RECORDS WERE ANALYZED AND NO ABNORMALITIES WERE FOUND DURING REVIEW OF PRODUCTION AND INSPECTION RECORDS OF LIOLI IOL DELIVERY SYSTEM, MODEL: LIOLI-24, LOT: GACM6009. INITIAL REPORTER INDICATED THAT THERE WAS VIDEO OF THE EVENT AVAILABLE FROM THE SURGEON INVOLVED, HOWEVER, AFTER MULTIPLE FOLLOW-UP ATTEMPTS, IT HAS NOT YET BEEN PROVIDED. INITIAL REPORTER ALSO INDICATED THAT THE SURGEON WOULD RETURN THE DEVICE INVOLVED, HOWEVER, AT THE TIME OF THIS REPORT, IT HAS NOT BEEN RECEIVED. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    INITIAL REPORTER STATED THAT A USER EXPERIENCED KICKBACK FROM LIOLI IOL DELIVERY SYSTEM PLUNGER DURING LENS INSERTION WHICH RESULTED IN IRIS PROLAPSE AND DISCHARGE FROM PRIMARY INCISION, AND THAT THE SURGEON IS MONITORING THE PATIENT FOR POSSIBLE CATARACT DEVELOPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286780 LIOLI IOL DELIVERY SYSTEM Folders and injectors, intraocular lens (iol) MSS AST PRODUCTS, INC. LIOLI-24 GACM6009

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention