BEUDAMED
    FDA Adverse Event Summary report: N

    OK 3 CONTACT LENS

    MDR report key: 11115 · Received January 26, 1994

    Report

    Report Number
    MW4000079
    Date Received
    January 26, 1994
    Report Date
    March 26, 1993
    Manufacturer
    CONTEX, INC.
    Product Code
    HQM
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RPTR IS AN OPHTHALMOLOGIST WHO ATTENDED A SEMINAR. AT THE SEMINAR HE WAS INFORMED THAT LENSES ARE IDE DEVICES NOT INTENDED FOR GENERAL SALE AND USE. DR PROMPTLY REQUESTED A REFUND FROM THE CO AND DISCONTINUED SALES OF THE PRODUCT. RPTR INDICATED THAT HE WOULD ASSIST IN AN INVESTIGATION OF SHIPPING PRACTICES OF THE CO. HE STATED THAT THE FIRM HAS BEEN MARKETING THESE DEVICES SINCE 1982 FOR ORTHOKERATOLOGY USAGE. HE ALSO STATED IN THE SAME CONVERSATION ON 4/12/93 THAT THE FIRM IS ADVERTISING THESE LENSES IN "ALL THE JOURNALS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OK 3 CONTACT LENS HQM CONTEX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *