BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1914376 · Received November 19, 2010

    Report

    Report Number
    1119421-2010-01280
    Event Type
    Other
    Date Received
    November 19, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 21, 2010
    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
    MA, 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. (B)(4).

    Description of Event or Problem · 1

    A FRIEND OF A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HIS FRIEND'S VISION IS NOT IMPROVED WHEN USING READING GLASSES. HE ALSO REPORTED THAT HIS FRIEND HAS DOUBLE VISION, IN WHICH "ONE OF THE DOUBLE IMAGES IS SKEWED- THE IMAGES ARE TILTED DOWNWARD." HE ALSO REPORTED THAT AN OPTOMETRIST TOLD HIS FRIEND HE NEEDED PRISM FOR HIS GLASSES. ACCORDING TO THE REPORTER, THE CONSUMER DOES NOT WANT THE SURGEON CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF 10988326

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other