BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KS-X

    MDR report key: 5536911 · Received March 30, 2016

    Report

    Report Number
    2023826-2016-00323
    Event Type
    Malfunction
    Date Received
    March 30, 2016
    Date of Event
    February 16, 2016
    Report Date
    February 29, 2016
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED IN THE (B)(4). BUT IS NOT MARKETED IN THE U.S. DIOPTER: +23.00 (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED PRODUCT FOUND THE IOL BLOCKED INSIDE THE LUMEN OF THE NOZZLE AND OVD WAS INJECTED. ROOT CAUSE WAS IDENTIFIED TO BE USER ERROR AS THE "HOLD POSITION" WHERE THE LENS SHOULD BE CONFIRMED WAS OBSERVED TO BE 8-10MM FROM THE TIP OF THE NOZZLE. THE RECOMMENDED METHOD IS TO HOLD THE LENS AT 4-6MM FROM THE TIP OF THE NOZZLE. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SURGEON USED A KS-X + 23.00 DIOPTER PRELOADED INJECTOR. PRIOR TO IMPLANTATION, THE LENS BECAME STUCK IN THE CARTRIDGE. NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189716 KS-X INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY KS-X NA

    Patients

    Seq Age Sex Outcome Treatment
    1