BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1220519 · Received October 29, 2008

    Report

    Report Number
    1119421-2008-00849
    Event Type
    Other
    Date Received
    October 29, 2008
    Date of Event
    March 23, 2006
    Report Date
    September 29, 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
    GA, 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 10/22/2008 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 10/23/2008. THIS REPORT WAS MAILED TO FDA ON: 10/29/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT EXPERIENCING GLARE AND FEELING LIKE SHE IS LOOKING THROUGH OIL FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY TWO YEARS AGO. IN A FOLLOW-UP, IN THE SURGEON'S OPINION, THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH LTD./HUNTINGTON SN60D3 943290

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other