BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1031123 · Received April 18, 2008

    Report

    Report Number
    1119421-2008-00262
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 19, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS AND VERIFIED TO HAVE SIGNS OF HANDLING. THE OPTIC WAS TORN/SPLIT (POSSIBLY CUT INTO TWO PIECES). THE OPTIC ALSO HAD A LARGE SCRAPE MARK-REJECTABLE. LENS BENCH TESTING COULD NOT BE CONDUCTED DUE TO THE OPTIC DAMAGE. WHILE WE ARE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MANUFACTURING RELATED. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED 04/10/2008 BY MAIL AND FAX. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 04/18/2008.

    Description of Event or Problem · 1

    A REGISTERED NURSE REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD BEEN EXPLANTED BECAUSE THE PT REPORTED GLARE AND POOR VISION. 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 10736880

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention