BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KS-NI2

    MDR report key: 4863956 · Received June 23, 2015

    Report

    Report Number
    2023826-2015-00711
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    May 22, 2015
    Report Date
    May 22, 2015
    Manufacturer
    STAAR JAPAN INC.
    Product Code
    HQL
    PMA / PMN Number
    N/A
    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 IS NOT MARKETED IN THE U.S. NO CONSEQUENCES OR IMPACT TO PATIENT; (LENS BECAME BLOCKED). DEVICE EVALUATED BY THE MANUFACTURER? NO. DEVICE WAS NOT RETURNED. EVALUATION CONCLUSION: (CONCLUSION NOT YET AVAILABLE) EVALUATION IS IN PROGRESS. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SURGEON USED A KS-NI2 19.0D PRELOADED INJECTOR ON (B)(6) 2015. WHEN HANDLING THE ROD OF THE DEVICE, THE ROD BECAME TOUGH TO PUSH AND THE LENS BECAME BLOCKED. NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405069 KS-NI2 INTRAOCULAR LENS HQL STAAR JAPAN INC. KS-NI2 19.0D N/A

    Patients

    Seq Age Sex Outcome Treatment
    1