BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1290887 · Received December 10, 2008

    Report

    Report Number
    1119421-2008-00995
    Event Type
    Other
    Date Received
    December 10, 2008
    Date of Event
    August 1, 2008
    Report Date
    November 10, 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
    IL, 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. ADDITIONAL INFORMATION WAS REQUESTED ON 11/11/2008, 11/19/2008, AND 11/20/2008 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 11/21/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTED HAVING RESIDUAL ASTIGMATISM, BLURRED VISION, DOUBLE VISION, AND SEEING A SHADOW IMAGE AT DISTANCE AND NEAR FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SHADOW IMAGE MAKES IT DIFFICULT TO READ SMALL PRINT. THE SURGEON REPORTED THAT A LIMBAL RELAXING INCISION (LRI) PROCEDURE HAS BEEN DONE FOR ASTIGMATISM. THE PT WAS ALSO PRESCRIBED GLASSES AND SEES FAIRLY WELL. THE SURGEON TOLD THE PT THAT THE SURGERY WAS SUCCESSFUL AND HE HAS NOT YET ADJUSTED TO THE IOL. ABOUT THREE WEEKS FOLLOWING SURGERY, MILD POSTERIOR CAPSULE OPACIFICATION (PCO) WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD3 10758781

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other