BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1211513 · Received October 17, 2008

    Report

    Report Number
    1119421-2008-00819
    Event Type
    Other
    Date Received
    October 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THERE WAS NO LOT NUMBER OR ANY IDENTIFICATION PROVIDED TRACEABLE TO THE MANUFACTURING DOCUMENTATION. AT THE CONSUMER'S REQUEST, THE SURGEON WAS NOT CONTACTED.

    Description of Event or Problem · 1

    A CONSUMER REPORTED POOR DISTANCE, INTERMEDIATE AND NEAR VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY IN 2005. SHE ALSO STATED VISION WAS BETTER AFTER SURGERY THAN WHAT SHE IS EXPERIENCING NOW. THE CONSUMER HAS A HISTORY OF AGE RELATED MACULAR DEGENERATION. AT THE CONSUMER'S REQUEST, THE SURGEON WAS NOT CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. SA60D3 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other