BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 931264 · Received October 19, 2007

    Report

    Report Number
    1119421-2007-00427
    Event Type
    Other
    Date Received
    October 19, 2007
    Date of Event
    January 1, 2007
    Report Date
    September 21, 2007
    Manufacturer
    ALCON LABORATORIES, INC. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. THIS REPORT WAS MAILED TO THE FDA ON: 10/19/2007. ADDITIONAL INFORMATION WAS REQUESTED 09/24/2007, 09/25/2007, AND 10/16/2007 BY PHONE, MAIL AND FAX. A COMPLETED QUESTIONAIRE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    A SURGEON REPORTS, AN UNEXPECTED POST-OPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION, INCLUDING PATIENT STATUS, HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. / HUNTINGTON SN6AD3 10732420

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other