BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTARR INJECTOR CARTRIDGE

    MDR report key: 33425 · Received June 14, 1996

    Report

    Report Number
    MW4001345
    Event Type
    Malfunction
    Date Received
    June 14, 1996
    Report Date
    February 28, 1995
    Manufacturer
    STARR SURGICAL CO.
    Product Code
    KYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROBLEM WITH CARTRIDGE INJECTOR SPLITTING WHILE INSERTING INTRAOCULAR LENS INTO THE EYE. WHEN INJECTOR SPLITS IT CAUSES DAMAGE TO THE INTRAOCULAR LENS IMPLANTS ON SOME OCCASIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTARR INJECTOR CARTRIDGE INJECTOR CARTRIDGE KYB STARR SURGICAL CO. 1-2MC-45LP CS0269

    Patients

    Seq Age Sex Outcome Treatment
    1 NA