BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1063490 · Received June 20, 2008

    Report

    Report Number
    1119421-2008-00467
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 23, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS AND WAS VERIFIED TO HAVE SIGNS OF HANDLING. WHILE WE WERE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATIONS REASONABLY SUGGEST THE DAMAGE IS NOT MANUFACTURING RELATED. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 06/05/2008 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 06/09/2008.

    Description of Event or Problem · 1

    A REGISTERED NURSE REPORTS THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A SCRATCH NOTICED AT THE FIRST POST-OPERATIVE VISIT. IN A FOLLOW-UP, THE SURGEON REPORTS THE OUTCOME OF EVENT FOR THE PT AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD/HUNTINGTON SN6AD3 10758716

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention VISCOELASTIC