BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1311169 · Received February 11, 2009

    Report

    Report Number
    1119421-2009-00075
    Event Type
    Injury
    Date Received
    February 11, 2009
    Date of Event
    May 28, 2008
    Report Date
    January 12, 2009
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; RESULT 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 01/19/2009 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 01/19/2009. THIS REPORT WAS MAILED TO FDA ON: 02/11/2009.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A PATIENT HAD AN INTRAOCULAR LENS (IOL) EXCHANGED FOR A DIFFERENT LENS MODEL DUE TO POOR NEAR AND INTERMEDIATE VISION. IN A FOLLOW UP, THE SURGEON REPORTED THE OUTCOME OF THE EVENT AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD3 10755979

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention