BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1202839 · Received October 17, 2008

    Report

    Report Number
    1119421-2008-00816
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 18, 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
    FR
    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 HAS BEEN ONE OTHER SIMILAR COMPLAINT REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED AND RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT ELEVEN MONTHS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT REPORTS BLURRY VISION, CONTRAST SENSITIVITY, HALOS, POOR INTERMEDIATE VISION AND POOR COLOR VISION. A LASIK PROCEDURE WAS PERFORMED THREE MONTHS FOLLOWING IMPLANT SURGERY. POSTERIOR CAPSULAR OPACIFICATION WAS NOTED FOUR MONTHS POSTOPERATIVELY AND A YAG LASER PROCEDURE WAS PERFORMED. THE SURGEON STATES THE PT HAS EXCELLENT VISUAL ACUITY WITHOUT CORRECTION. 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 SN60D3 10713225

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention DUOVISC