BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1001544 · Received February 21, 2008

    Report

    Report Number
    1119421-2008-00083
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 22, 2008
    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
    MD, US
    Reporter Occupation
    OTHER

    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 ARE NO COMPLAINTS IN THE LOT. ADDITIONAL INFO WAS REQUESTED FROM THE SURGEON ON 1/24/2008 BY FAX AND BY MAIL AND ON 2/1/2008 BY PHONE. ADDITIONAL INFO HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 02/21/2008.

    Description of Event or Problem · 1

    THE SURGEON REPORTED, AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO DISLOCATION. IT WAS ALSO REPORTED THAT THE REPLACEMENT LENS WAS A DIFFERENT DIOPTER. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD/ HUNTINGTON SN6AD3 10739910

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Required Intervention