BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1022536 · Received March 20, 2008

    Report

    Report Number
    1119421-2008-00190
    Event Type
    Other
    Date Received
    March 20, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 13, 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
    MS, 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 CONSUMER'S REQUEST, THE SURGEON WAS NOT CONTACTED. THIS REPORT WAS MAILED TO FDA ON: 03/27/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTS POOR VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SHE STATES SHE SEES OBJECTS IN BLACK AND WHITE, AND EVERYTHING IS DISTORTED AND WAVY. AT THE CONSUMER'S REQUEST, THE SURGEON WAS NOT CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 10759800

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other