BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELASTIC LENS

    MDR report key: 619368 · Received July 1, 2005

    Report

    Report Number
    2023826-2005-00845
    Event Type
    Injury
    Date Received
    July 1, 2005
    Date of Event
    May 25, 2005
    Report Date
    June 1, 2005
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON IMPLANTED A AA4207VF PLATE SILICONE LENS. THE LENS TORE UPON INSERTION INTO THE EYE. THE INCISION WAS ENLARGED TO REMOVE THE LENS. IT WAS UNKNOWN WHAT CAUSED THE LENS TO TEAR. THE INJECTOR MODEL WAS USED WAS A MSI-TR, THE REPORTER WAS UNABLE TO PROVIDE THE LOT NUMBER AND THE CARTRIDGE MODEL THAT WAS USED WAS A ST-45, LOT NUMBER 1191760.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELASTIC LENS INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4207VF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention