BEUDAMED
    FDA Adverse Event Other Summary report: N

    OCUSCAN RXP

    MDR report key: 1821688 · Received August 27, 2010

    Report

    Report Number
    2028159-2010-01618
    Event Type
    Other
    Date Received
    August 27, 2010
    Report Date
    July 28, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    IYO
    PMA / PMN Number
    K842757
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "POOR POST OPERATIVE OUTCOME" (POSTOPERATIVE REFRACTION, UNEXPECTED). PRODUCT PROBLEM(S): "CONTACT SELECTED BUT IMMERSION USED TO CALCULATE IOL" (INCORRECT SOFTWARE PROGRAMMING CALCULATIONS). A CUSTOMER REPORTED POOR POST-OPERATIVE OUTCOMES. THE PT'S PRE-OPERATIVE EXAMINATION WAS DONE WITH AN IMMERSION TECHNIQUE AND THE EQUIPMENT WAS SET FOR A CONTACT TECHNIQUE (SELECTED BY USER). TWO PTS WERE INVOLVED AND NOW HAVE UNSATISFACTORY RESULTS. THIS IS NOT A DEVICE RELATED ADVERSE EVENT OR MALFUNCTION. INCORRECT SETTINGS WERE CHOSEN BY THE USER, RESULTING THE UNSATISFACTORY POST-OPERATIVE OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other