BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KS-1

    MDR report key: 4201338 · Received October 27, 2014

    Report

    Report Number
    2023826-2014-00893
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 25, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. PT AGE AND WEIGHT: UNKNOWN. (B)(4). METHOD: DEVICE WORK ORDER SEARCH. RESULTS: A DEVICE WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND. 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-1 AQ2017V 22.5D PRELOADED INJECTOR. WHEN PUSHING THE SCREW PLUNGER/ADVANCING THE LENS IN THE INJECTOR, THE LENS ROTATED AND BECOME STUCK. NO PATIENT CONTACT. CAUSE OF INCIDENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684503 KS-1 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY KS-1 AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1