BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1734066 · Received June 18, 2010

    Report

    Report Number
    1119421-2010-00717
    Event Type
    Other
    Date Received
    June 18, 2010
    Date of Event
    January 1, 2010
    Report Date
    May 19, 2010
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. AT THE REQUEST OF THE CONSUMER, HER SURGEON WAS NOT CONTACTED. (B) (4). (B) (4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "CANNOT SEE INTERMEDIATE OR FAR VISION AND POOR DEPTH PERCEPTION" (VISION, IMPAIRED). PRODUCT PROBLEM(S): "NO INFORMATION" (NO INFORMATION [IOL (INTRAOCULAR LENS) IMPLANT]). A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE CANNOT SEE AT INTERMEDIATE OR FAR DISTANCES AND HAS NO DEPTH PERCEPTION. THE CONSUMER REPORTED THAT SHE CANNOT SEE DETAIL OF OBJECTS 50 FEET AWAY AND EDGES ARE NOT SHARP. SHE ALSO HAS TROUBLE SEEING PRODUCTS ON THE SHELVES AT THE GROCERY STORE. THE CONSUMER REPORTED, SHE IS ABLE TO READ VERY WELL. AT THE REQUEST OF THE CONSUMER, HER SURGEON WAS NOT CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 10902066

    Patients

    Seq Age Sex Outcome Treatment
    1 Other