BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1052746 · Received May 23, 2008

    Report

    Report Number
    1119421-2008-00358
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 25, 2008
    Manufacturer
    ALCON MANUFACTURING, LTD./HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. ADD'L INFO HAS BEEN REQUESTED. THIS REPORT WAS MAILED TO FDA ON: 05/23/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A SCRATCH WAS NOTED ON THE OPTIC. THERE WAS NO PT IMPACT. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON MANUFACTURING, LTD./HUNTINGTON SA60D3 10751999

    Patients

    Seq Age Sex Outcome Treatment
    1 NA