BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1534746 · Received November 18, 2009

    Report

    Report Number
    9612169-2009-00019
    Event Type
    Other
    Date Received
    November 18, 2009
    Date of Event
    January 1, 2009
    Report Date
    October 19, 2009
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. (B) (4). (B) (4).

    Description of Event or Problem · 1

    TEN MONTHS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A SURGEON REPORTED A PT EXPERIENCING POSITIVE DYSPHOTOPSIA. THE PT DESCRIBED SEEING A CURVED GLARE, BEAM OF LIGHT AT THE EDGE OF THE LENS. IN A FOLLOW UP, THE SURGEON REPORTED THE EVENT CONTINUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SA60AT 20811788

    Patients

    Seq Age Sex Outcome Treatment
    1 Other