BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1527053 · Received November 12, 2009

    Report

    Report Number
    1119421-2009-01077
    Event Type
    Other
    Date Received
    November 12, 2009
    Date of Event
    July 1, 2009
    Report Date
    October 13, 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
    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 ON 10/14/2009, 10/15/2009, AND 10/18/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. MEDICAL RECORDS WERE RECEIVED ON 10/16/2009. (B) (4). (B) (4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT WAS EXPERIENCING GLARE OFF OF FLAT SURFACES. THE SURGEON REPORTED THE PT IS DISSATISFIED WITH HIS RESULTS, DESPITE HAVING GOOD VISUAL ACUITIES. THE PT HAS HAD A SECOND OPINION AND WAS TOLD HE HAD AN EXCELLENT RESULT AND THAT NO OTHER PROCEDURES WOULD BE RECOMMENDED. ADDITIONAL INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 10876113

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other