BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR CARTRIDGE

    MDR report key: 1912283 · Received November 24, 2010

    Report

    Report Number
    2023826-2010-01200
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 11, 2010
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    KYB
    PMA / PMN Number
    K954600
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PRODUCT PERTAINING TO THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LENS WAS RETURNED AND VISUAL INSPECTION FOUND THE OPTIC TORN. PIECE OF OPTIC AND HAPTIC TORN OFF AND MISSING. EVALUATION METHOD - CARTRIDGE LOT NUMBER SEARCH. RESULTS - CARTRIDGE LOT NUMBER SEARCH WAS PERFORMED AND FOUR SIMILAR COMPLAINTS WERE FOUND WITHIN THE SAME LOT NUMBER. CONCLUSIONS - BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, POSSIBLE ROOT CAUSES FOR LENS TEARS INCLUDE BOTH DELIVERY SYSTEM ISSUES AND POSSIBLE HANDLING ERRORS BY THE CUSTOMER. A MULTIFUNCTIONAL TEAM INVESTIGATED COMPLAINTS REGARDING LENS TEARS ASSOCIATED WITH THE CQ CARTRIDGE: THE RESULTANT CORRECTIVE ACTIONS INCLUDED IMPROVEMENTS IN MANUFACTURING, RELEASE TESTING, AND EVALUATION 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. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A 21.0 DIOPTER CQ2015A COLLAMER ASPHERIC THREE PIECE LENS. THE HAPTIC BROKE UPON INSERTION INTO THE EYE. THE LENS WAS REMOVED WITH NO PT INJURY. ANOTHER SAME MODEL AND SIZE LENS WAS IMPLANTED. REPORTER STATED THE CARTRIDGE DAMAGED THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR CARTRIDGE INTRAOCULAR LENS GUIDE KYB STAAR SURGICAL COMPANY CQ CARTRIDGE-FP 1254557

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR LENS MODEL CQ2015A - (B)(4)| INJECTOR MODEL - MSI-PM - LOT NUMBER - UNK