BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1061725 · Received June 13, 2008

    Report

    Report Number
    1119421-2008-00427
    Event Type
    Other
    Date Received
    June 13, 2008
    Report Date
    May 14, 2008
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    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 WAS REQUESTED ON 05/19/2008 AND 06/02/2008 BY PHONE, MAIL AND FAX. THIS REPORT WAS MAILED TO FDA ON: 06/13/2008.

    Description of Event or Problem · 1

    A CONSUMER, FOLLOWING INTRAOCULAR LENS (IOL) SURGERY, REPORTED GLARE AND HER EYE IS SORE TO THE TOUCH. SHE ALSO REPORTED THAT OTHERS CAN SEE THE REFLECTION OF THE LENS IN HER EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SA60AT 942756

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other