BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIOLI IOL DELIVERY SYSTEM

    MDR report key: 22008615 · Received May 13, 2025

    Report

    Report Number
    1000635309-2025-00001
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    March 5, 2025
    Report Date
    May 13, 2025
    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

    DEVICE LOT NUMBER WAS NOT PROVIDED BY THE REPORTER AND THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. DHR FOR THE DEVICE USED COULD NOT BE REVIEWED AS A LOT NUMBER WAS NOT PROVIDED. ROOT CAUSE WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT INFORMATION.

    Description of Event or Problem · 0

    REPORTER STATED THAT A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED A LOW VAULT, AND LENS TEAR/BREAK DURING INJECTION/DELIVERY INTO THE EYE WAS ALSO REPORTED. AN IRIS SUTURE WAS PERFORMED DUE TO IRIS PROLAPSE. THE LENS WAS EXPLANTED. CAUSE REPORTED AS DEVICE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2370726 LIOLI IOL DELIVERY SYSTEM LIOLI IOL DELIVERY SYSTEM MSS AST PRODUCTS, INC. LIOLI-24

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention