BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KS-NI2

    MDR report key: 4222152 · Received November 3, 2014

    Report

    Report Number
    2023826-2014-00930
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 10, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: DATA ANALYSIS PERFORMED BY STAAR JAPAN DETERMINED THAT THE PERFORMANCE OF THE PRELOADED INJECTOR SYSTEM DEGRADED WITH AGING AFTER STERILIZATION AND THIS IS MORE FREQUENT IN LOW DIOPTERS (12.5D-16.0D). IN ADDITION, THE MECHANISM OF THE IRREGULARITY (LENS DOES NOT TRAVEL AS INTENDED) WAS IDENTIFIED. THE KEY FINDINGS WAS THE NATURE OF THE LENS PER DIFFERENT DIOPTER SIZES. THE LOW DIOPTER LENSES (12.5D-16.0D) CONTACT MORE ON THE BOTTOM AND CEILING OF THE CARTRIDGE COMPARED TO THE MEDIUM AND HIGH DIOPTER LENSES. THEREFORE, IT IS CONCLUDED THAT THE ROOT CAUSE OF THIS NONCONFORMITY IS THE DESIGN OF THE PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED IN THE U.S BUT NOT MARKETED IN THE U.S. PT AGE AND WEIGHT: UNK. (B)(4). METHOD: DEVICE WORK ORDER SEARCH. RESULTS: A DEVICE WORK ORDER SEARCH WAS PERFORMED AND ONE SIMILAR COMPLAINT WERE FOUND WITHIN THE WORK ORDER. CONCLUSION: CONCLUSION NOT YET AVAILABLE. EVALUATION IS IN PROGRESS. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON ATTEMPTED TO USE A KS-NI2 AQ310AIN PRE-LOADED INJECTOR. WHILE ADVANCING THE LENS WITH THE SCREW PLUNGER, THE LENS ROTATED AND GOT STUCK IN THE INJECTOR. NO PATIENT CONTACT. CAUSE OF INCIDENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702137 KS-NI2 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY KS-NI2 AQ310AIN NA

    Patients

    Seq Age Sex Outcome Treatment
    1