BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1200368 · Received October 10, 2008

    Report

    Report Number
    1119421-2008-00796
    Event Type
    Other
    Date Received
    October 10, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 11, 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
    WV, US
    Reporter Occupation
    OTHER

    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. ADDITIONAL INFORMATION WAS REQUESTED ON 09/12/2008 AND 09/22/2008 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTS A PATIENT WHO IS SEEING A BLUE HAZE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PATIENT WAS REFERRED TO A RETINAL SPECIALIST AND WAS TOLD THERE WERE NO RETINAL FINDINGS. THE SURGEON REPORTS NO COMPLICATIONS DURING SURGERY, AND THE PATIENT'S VISUAL OUTCOME AS "EXCELLENT". ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 10821913

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other