BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR CARTRIDGE

    MDR report key: 1054650 · Received May 30, 2008

    Report

    Report Number
    2023826-2008-00767
    Event Type
    Malfunction
    Date Received
    May 30, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 5, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    KYB
    PMA / PMN Number
    P954600
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: JOS A MULTIFUNCTIONAL TEAM INVESTIGATED COMPLAINTS REGARDING LENS TEARS ASSOCIATED WITH THE CQ CARTRIDGE; THE RESULTANT CORRECTIVE ACTIONS INCLUDED IMPROVEMENTS IN MFG, RELEASE TESTING, AND EVAL OF TEST RESULTS. ADDITIONALLY, THE INJECTOR/CARTRIDGE DIRECTIONS FOR USE (DFU) HAVE BEEN MODIFIED TO ADD FURTHER CLARIFICATIONS TO INSTRUCT THE USERS IN THE PROPER DELIVERY TECHNIQUES THAT ARE EFFECTIVE, AND MINIMIZE THE POTENTIAL FOR DAMAGING THE LENS. THIS COMPLAINT FILE WILL BE CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS ATTEMPTING TO INSERT A +23.0 DIOPTER CQ2015A SILICONE THREE PIECE LENS AND THE LENS WAS DAMAGED IN THE CARTRIDGE. NO PT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR CARTRIDGE INTRAOCULAR LENS KYB STAAR SURGICAL CO. CQ CARTRIDGE-FP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LENS MODEL CQ2015A| INJECTOR MODEL MSI-TM