BEUDAMED
    FDA Adverse Event Summary report: N

    TEUTON

    MDR report key: 27046 · Received October 5, 1995

    Report

    Report Number
    MW4000819
    Date Received
    October 5, 1995
    Manufacturer
    VISX, INC.
    Product Code
    HQF
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS COMPLAINT INVOLVED A CLINICAL TESTING OF COMPUTERIZED COLD (PRK) LASER STUDIES. RPTR HAD ENTERED THE STUDY DURING THE 3RD PHASE AND HAD PAID $1500 FOR TREATMENT. PROTOCOL CALLED FOR RETREATMENT IF LESS THAN 20/40 VISION HAD BEEN OBTAINED, AND ON 4/2/93 SHE HAD A SECOND TREATMENT THAT RESULTED IN 20% VISION RESTORED. DR ATTEMPTED TO RESCHEDULE A THIRD TREATMENT WITH FAVORABLE PROGNOSIS BUT WAS UNABLE TO CONTINUE TREATMENT BECAUSE DEVICE HAD BEEN BOUGHT OUT BY COMPETITOR AND ALL CLINICAL TESTING OF DEVICE HAD BEEN TERMINATED. RPTR IS UNABLE TO BE INCLUDED IN OTHER PRK CLINICAL TESTS DUE TO HER PARTICIPATION IN THE PROGRAM. RPTR IS ELDERLY AND HAS BEEN BLIND FROM BIRTH AND FEARS SHE WILL NOT LIVE LONG ENOUGH FOR APPROVAL OF THE PRK STUDIES COMPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEUTON PRK LASER HQF VISX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *