BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHIRON CORNEO GAGE II

    MDR report key: 31339 · Received January 4, 1994

    Report

    Report Number
    53295-1993-09001
    Event Type
    Malfunction
    Date Received
    January 4, 1994
    Date of Event
    December 2, 1993
    Report Date
    December 29, 1993
    Manufacturer
    SONOGAGE INC
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ULTRASONIC PACHYMETER MEASURING 30-40 MICRONS TOO DEEP ACCORDING TO SUBSEQUENT CLINICAL AND FACTORY CALIBRATION OF THE INSTRUMENT. THIS INACCURACY OF MEASUREMENTS RESULTED IN ABNORMALLY DEEP SETTINGS ON THE DIAMOND BLAD PRODUCING CORNEAL MICROPERFORATIONS IN 2 OUT OF 3 REFRACTIVE SURGERY PATIENTS DONE THAT DAY (12/2/93)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHIRON CORNEO GAGE II PACHOMETER (CORNEAL) HQC SONOGAGE INC CORNEO GAGE II

    Patients

    Seq Age Sex Outcome Treatment
    1 *