BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1821628 · Received August 18, 2010

    Report

    Report Number
    1119421-2010-00901
    Event Type
    Other
    Date Received
    August 18, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 19, 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
    TX, 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 SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. AT THE CONSUMER'S REQUEST, THE SURGEON WAS NOT CONTACTED. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NOT SEEING 20/20" (VISION, IMPAIRED). PRODUCT PROBLEM(S): "NO INFORMATION" (NO INFORMATION [IOL (INTRAOCULAR LENS) IMPLANT]). A CONSUMER REPORTED THAT SHE WAS NOT SEEING 20/20 15 DAYS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SHE STATED SHE UNDERSTOOD THAT SHE WAS STILL RECOVERING FROM SURGERY. 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 11002869

    Patients

    Seq Age Sex Outcome Treatment
    1 Other