BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 1052747 · Received May 23, 2008

    Report

    Report Number
    1119421-2008-00373
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 24, 2008
    Manufacturer
    ALCON RESEARCH, LTD./ HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 4/29/2008 BY MAIL AND BY FAX, ON 5/6/2008 AND 5/20/2008 BY PHONE.

    Description of Event or Problem · 1

    A NURSE STATED THE SURGEON NOTICED BUBBLES IN AN INTRAOCULAR LENS (IOL) AFTER IT WAS IMPLANTED. THE LENS REMAINS IMPLANTED. ADD'L INFO WAS RECEIVED FROM THE SURGEON. IT WAS REPORTED HE NOTICED 20 PINPOINT BUBBLES AS SOON AS THE LENS WAS IMPLANTED. THE BUBBLES ACTUALLY MAGNIFIED THE RETINA AND ALLOWED HIM TO VIEW THE RETINA. THE SURGEON STATED HE DID NOT FEEL THE BUBBLES IMPACTED THE PT'S VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./ HUNTINGTON SN60WF 10805619

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PROVISC