BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1353569 · Received March 19, 2009

    Report

    Report Number
    1119421-2009-00226
    Event Type
    Other
    Date Received
    March 19, 2009
    Date of Event
    January 1, 2009
    Report Date
    February 17, 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
    CA, US
    Reporter Occupation
    OTHER

    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. ADDITIONAL INFORMATION WAS REQUESTED ON 02/18/2009, 02/20/2009, AND 03/09/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 03/19/2009.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT HAVING DIFFICULTY SEEING AT NEAR AND DISTANCE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. 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 SN6AD3 10723205

    Patients

    Seq Age Sex Outcome Treatment
    1 Other