BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1027634 · Received April 10, 2008

    Report

    Report Number
    1119421-2008-00220
    Event Type
    Other
    Date Received
    April 10, 2008
    Date of Event
    December 1, 2007
    Report Date
    March 11, 2008
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED 03/11/2008, 03/17/2008 AND 03/24/2008 BY FAX, MAIL AND PHONE. A COMPLETED QUESTIONNAIRE WAS RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 04/10/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTS THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE STILL CANNOT SEE WELL. SHE IS NOW REQUIRED TO WEAR GLASSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN60D3 10718432

    Patients

    Seq Age Sex Outcome Treatment
    1 Other