BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1002955 · Received February 6, 2008

    Report

    Report Number
    1119421-2008-00042
    Event Type
    Other
    Date Received
    February 6, 2008
    Report Date
    January 7, 2008
    Manufacturer
    ALCON MANUFACTURING, LTD./ HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    UNKNOWN

    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 01/16/2008 AND 01/18/2008 BY PHONE FAX AND MAIL. PT RECORDS WERE RECEIVED 01/18/2008. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    A CONSUMER REPORTS THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE HAS A WRINKLE IN HER EYE. SHE REPORTS HER DISTANCE VISION IS GOOD, BUT SHE CANNOT SEE TO READ. THE SURGEON REPORTS THE WRINKLE IS IN THE POSTERIOR CAPSULE. ADD'L INFO, INCLUDING PT STATUS, HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON MANUFACTURING, LTD./ HUNTINGTON SN60D3 957352

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other