BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR® INJECTOR CARTRIDGE

    MDR report key: 2250329 · Received September 15, 2011

    Report

    Report Number
    2023826-2011-00793
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 18, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    KYB
    PMA / PMN Number
    K954600
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO CONSEQUENCES OR IMPACT TO PATIENT, LENS, DAMAGED BY CARTRIDGE. EVALUATION METHOD: WORK ORDER SEARCH. RESULTS: A LOT WORK ORDER SEARCH WAS PERFORMED AND THERE WAS TWO SIMILAR COMPLAINTS FOUND FROM THE SAME CUSTOMER, WITH THE SAME DATE OF INCIDENT. CONCLUSION: 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).

    Additional Manufacturer Narrative · 1

    EVALUATION - VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THE LENS WAS RETURNED IN LIQUID AND THE OPTIC WAS TORN. (B)(4)

    Description of Event or Problem · 1

    THE REPORTER STATED "THESE LENSES WERE DAMAGED DURING SURGERY. ALL HAD PATIENT CONTACT WITH NO INJURY. THE FACILITY CONCLUDED THAT THE CARTRIDGES WERE TOO TIGHT FOR THE LENSES TO SLIDE OUT". SEE MFR #2023826-2011-00794 AND #2023826-2011-00795 FOR THE OTHER LENSES.

    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 1259973

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR LENS: MODEL CQ2015A, (B)(4)| STAARVISC II: LOT NUMBER UNKNOWN