BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR CARTRIDGE

    MDR report key: 1002705 · Received February 26, 2008

    Report

    Report Number
    2023826-2008-00268
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Report Date
    February 1, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    KYB
    PMA / PMN Number
    K954600
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: CARTRIDGE LOT NUMBER SEARCH. RESULTS: A CARTRIDGE LOT NUMBER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND. CONCLUSIONS: (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY AND LOT NUMBER SEARCH, A SPECIFICATION ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. IT SHOULD BE NOTED THAT THE CARTRIDGE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON FELT AN AQ CARTRIDGE-FP, LOT NUMBER 1233760 SEEMED DIFFERENT. NO FURTHER INFO WAS PROVIDED WAS PROVIDED BUT IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR CARTRIDGE INTRAOCULAR LENS GUIDE KYB STAAR SURGICAL CO. AQ CARTRIDGE-FP 1233760

    Patients

    Seq Age Sex Outcome Treatment
    1 LENS MODEL AND SERIAL NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK