BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR CARTRIDGE

    MDR report key: 1000704 · Received February 21, 2008

    Report

    Report Number
    2023826-2008-00227
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    December 11, 2007
    Report Date
    January 24, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    KYB
    PMA / PMN Number
    K954600
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONSEQUENCES OR IMPACT TO PT, LENS TWISTING IN CARTRIDGE, EVALUATION: RESULTS: A LOT NUMBER SEARCH WAS PERFORMED FOR THE INJECTOR AND CARTRIDGE FOR SIMILAR COMPLAINTS WITHIN THE SEARCH AND THERE WERE NO SIMILAR COMPLAINTS FOR THE CARTRIDGE LOT NUMBER AND FOUR SIMILAR COMPLAINTS FOR THE INJECTOR LOT NUMBER.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON WAS ADVANCING A EYEONICS LENS IN A MSI-PF AND MTC-60CFP CARTRIDGE AND HE NOTICED THE LENS BEGAN TWISTING IN THE INJECTOR. NO PT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR CARTRIDGE INTRAOCULAR LENS GUIDE KYB STAAR SURGICAL MTC-60CFP 123260

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR MODEL: MSI-PF