BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 908299 · Received August 31, 2007

    Report

    Report Number
    1119421-2007-00360
    Event Type
    Other
    Date Received
    August 31, 2007
    Date of Event
    January 1, 2007
    Report Date
    August 2, 2007
    Manufacturer
    ALCON LABORATORIES, INC./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE 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 08/02/2007, 08/03/2007, 08/14/2007 AND 08/23/2007 BY PHONE, MAIL AND FAX. A FOLLOW-UP QUESTIONNAIRE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    A CONSUMER REPORTS BLURRY NEAR VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION, INCLUDING PATIENT STATUS, HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC./HUNTINGTON SN60D3 10604565

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other