BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1283375 · Received January 8, 2009

    Report

    Report Number
    1119421-2008-01087
    Event Type
    Injury
    Date Received
    January 8, 2009
    Date of Event
    December 30, 2008
    Report Date
    December 9, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 12/10/2008, 12/12/2008, 12/23/2008, AND 01/05/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 01/08/2009.

    Description of Event or Problem · 1

    A SURGEON REPORTED AN INTRAOCULAR LENS (IOL) WAS REPLACED DUE TO AN UNEXPECTED POSTOPERATIVE REFRACTION. THE SURGEON ALSO REPORTED QUESTIONABLE PITTING IN THE CENTER OF THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SA60D3 159783

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention