BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCUSCAN RXP

    MDR report key: 4121399 · Received July 28, 2014

    Report

    Report Number
    2028159-2014-01389
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    IYO
    PMA / PMN Number
    K842757
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE EQUIPMENT'S MEASUREMENTS WERE NOT AS EXPECTED DURING THE EXAM. THE MEASUREMENT HAD A SHORT LENGTH AND HIGH CURVATURE OF THE CORNEA. THE EXAM WAS COMPLETED WITH OTHER EQUIPMENT TO CONFIRM THE MEASURES. THERE WAS NO HARM TO THE PATIENT. THIS IS THE FIRST OF TWO REPORTS FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440057 OCUSCAN RXP ULTRASONIC PULSED ECHO IMAGING SYSTEM IYO ALCON - IRVINE TECHNOLOGY CENTER 8065741076 NA

    Patients

    Seq Age Sex Outcome Treatment
    1