BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCUSCAN RXP

    MDR report key: 1030839 · Received April 17, 2008

    Report

    Report Number
    2028159-2008-00137
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 18, 2008
    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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE AND SALES REP EXAMINED THE SYSTEM AND FOUND THE SYSTEM MET ALL PRODUCT SPECS. NO OTHER COMPLAINTS WERE REPORTED FOR THIS SYSTEM. A SERVICE REQUEST TREND REVIEW NOTED NO ADVERSE TRENDING FOR THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED ISSUE IS USER ERROR: THE TECHNIQUE USED IS CLEARLY SHOWN ON THE SCREEN WHILE THE READING IS BEING TAKEN. OPERATORS OF THE SYSTEM ARE TO BE TRAINED PROFESSIONALS WITH A GOOD UNDERSTANDING OF HOW THE EQUIPMENT OPERATES. THE OPERATOR'S MANUAL REVIEWS THE CONTACT VERSUS IMMERSION TECHNIQUE AND INCLUDES A WARNING THAT THE CORRECT TECHNIQUE MUST BE SELECTED. A TECHNICAL SERVICES ARTICLE SENT TO TECHNICAL SERVICES GLOBALLY REITERATES THE IMPORTANCE OF SELECTING THE CORRECT TECHNIQUE. A COPY OF THE PAGES CITED IN THE OPERATOR'S MANUAL AND THE TECHNICAL SERVICES ARTICLE WERE SENT TO THE AFFILIATE FOR REVIEW. THIS REPORT MAILED IN TO FDA ON: 04/17/2008.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INCORRECT MEASUREMENTS WITH THE SYSTEM. A PT RECEIVED THE WRONG INTRAOCULAR LENS BECAUSE OF AN INCORRECT LENS MEASUREMENT. THE SURGEON STATED THAT THE ROOT CAUSE OF THE IOL MISCALCULATION WAS DUE TO THE FACT THAT THE SYSTEM WAS SET FOR IMMERSION READINGS WHEN THE ACTUAL TECHNIQUE BEING USED WAS THE CONTACT METHOD. THE SURGEON DOES NOT FAULT THE SYSTEM AND DECLINED TO COMPLETE THE QUESTIONNAIRE. THE SURGEON MAY NEED TO PERFORM ANOTHER SURGERY TO REPLACE THE IOL. HOWEVER, NO INFO HAS BEEN RECEIVED THAT THIS SURGERY HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCUSCAN RXP OPHTHALMIC MEASURING DEVICE IYO ALCON-IRVINE TECHNOLOGY CENTER OCUSCAN RXP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other