BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 909454 · Received September 7, 2007

    Report

    Report Number
    1119421-2007-00368
    Event Type
    Injury
    Date Received
    September 7, 2007
    Date of Event
    January 1, 2007
    Report Date
    August 8, 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
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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: 07/07/2007. ADDITIONAL INFORMATION WAS REQUESTED 08/13/2007, 08/14/2007, 08/15/2007 AND 08/24/2007. A COMPLETED QUESTIONAIRE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    A REPRESENTATIVE FROM A PHYSICIAN'S OFFICE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT REPORTED BLURRY VISION AND HALOS. THE LENS WAS EXCHANGED. THE REPRESENTATIVE REPORTS THAT PATIENT IS DOING WELL FOLLOWING LENS EXCHANGE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES, INC./HUNTINGTON SN60D3 976707

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention