BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1784701 · Received July 30, 2010

    Report

    Report Number
    1119421-2010-00869
    Event Type
    Injury
    Date Received
    July 30, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 30, 2010
    Manufacturer
    ALCON RESEARCH LTD./HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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 07/01/2010, 07/06/2010 AND 07/12/2010 BY PHONE, FAX, AND MAIL. ADDITIONAL INFORMATION WAS RECEIVED BY PHONE ON 07/12/2010. THE SURGEON WAS UNWILLING TO COMPLETE THE QUESTIONNAIRE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "BLURRY VISION" (BLURRED VISION). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFORMATION [IOL (INTRAOCULAR LENS) IMPLANT]). A USER FACILITY REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED. IN A FOLLOW UP PHONE CALL WITH THE SURGEON, HE REPORTED THAT IOL WAS EXCHANGED BECAUSE THE PT WAS EXPERIENCING BLURRY VISION. THE SURGEON WAS UNWILLING TO COMPLETE THE QUESTIONNAIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH LTD./HUNTINGTON SN6AD1 11011532

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention