BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IOL

    MDR report key: 33326 · Received April 26, 1996

    Report

    Report Number
    MW4001333
    Event Type
    Malfunction
    Date Received
    April 26, 1996
    Report Date
    April 22, 1996
    Manufacturer
    U.S. IOL, INC.
    Product Code
    IOL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    TRADE COMPLAINT PERTAINING TO COMPETITOR ALLEGEDLY SHIPPING INVESTIGATIONAL USE INTRAOCULAR LENS (IOL'S) TO FOREIGN COUNTRIES FOR COMMERCIAL SALE. COMPLAINANT HAD ONE BOX OF IOL'S LABELED AS INVESTIGATIONAL USE FROM COMPETITOR, WHICH HE STATES WAS OBTAINED FROM A FOREIGN COUNTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IOL INTRAOCULAR LENS IOL U.S. IOL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA