BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 1083148 · Received July 24, 2008

    Report

    Report Number
    2023826-2008-00977
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 26, 2008
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MSS
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON INSERTED A COMPETITOR'S LENS USING A MSI INJECTOR AND A HAPTIC TORE AS THE LENS EXITED THE INJECTOR. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR INTRAOCULAR LENS FOLDERS AND INJECTORS MSS STAAR SURGICAL COMPANY UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CARTRIDGE MODEL UNKNOWN