BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1202789 · Received October 16, 2008

    Report

    Report Number
    1119421-2008-00806
    Event Type
    Other
    Date Received
    October 16, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 16, 2008
    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
    AZ, 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 INFO WAS REQUESTED VIA PHONE ON 09/16/2008, AND VIA FAX AND MAIL ON 09/17/2008. THIS REPORT WAS MAILED TO FDA ON: 10/16/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT EXPERIENCED A MYOPIC SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD3 10776137

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other MURO 128| PREDFORTE| VIGAMOX| NEVANAC