BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1230253 · Received November 7, 2008

    Report

    Report Number
    1119421-2008-00894
    Event Type
    Other
    Date Received
    November 7, 2008
    Date of Event
    September 11, 2008
    Report Date
    October 9, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    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. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A SURGEON REPORTS HAVING TWO PATIENTS WITH BLURRY VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. GLISTENINGS WERE NOTED UPON EXAMINATION OF THE LENSES. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT IS FOR THE SECOND PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60AT 837888

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other