BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KS-NI2

    MDR report key: 8567186 · Received April 30, 2019

    Report

    Report Number
    2023826-2019-00718
    Event Type
    Malfunction
    Date Received
    April 30, 2019
    Date of Event
    March 20, 2019
    Report Date
    April 4, 2019
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT MARKETED IN THE US. IOL WAS ROTATED AND REMAINED INSIDE THE NOZZLE. VOLUME OF USED VISCOELASTIC MATERIAL APPEARED TO BE ENOUGH. NO SIMILAR COMPLAINT TYPE EVENTS WERE REPORTED FOR UNITS WITHIN THE SAME LOT. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT UPON HANDLING THE ROD OF A KS-NI2 AQ310AIN, 13.0 DIOPTER, PRELOADED INJECTOR THE LENS BECAME BLOCKED. THE SURGERY WAS SUCCESSFULLY COMPLETED BY USING ALTERNATIVE PRELOAD WITHIN THE SAME SURGERY. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359994 KS-NI2 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY KS-NI2 AQ310AIN N/A

    Patients

    Seq Age Sex Outcome Treatment
    1