BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1023770 · Received March 21, 2008

    Report

    Report Number
    1119421-2008-00169
    Event Type
    Other
    Date Received
    March 21, 2008
    Date of Event
    January 1, 2000
    Report Date
    February 22, 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
    CA, 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. ADDITIONAL INFORMATION WAS REQUESTED 03/04/2008 BY FAX AND EMAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    EIGHT YEARS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, CONSUMER REPORTS THAT SHE HAS NEVER BEEN SATISFIED WITH THE RESULTS. SHE REPORTS HALOS AND STARBURSTS THAT MAKE DRIVING AT NIGHT DIFFICULT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON MA30BA 555744

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other