BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1756914 · Received July 2, 2010

    Report

    Report Number
    1119421-2010-00768
    Event Type
    Other
    Date Received
    July 2, 2010
    Date of Event
    April 1, 2010
    Report Date
    June 2, 2010
    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
    NY, 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 06/04/201006/07/2010, 06/22/2010 AND 06/24/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "POOR NEAR VISION (VISION, IMPAIRED). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFO [IOL (INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED, A PT WITH POOR NEAR VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTED, THE PT HAS TIGHT, DROOPY EYE LIDS AND HAS 7 DIOPTER'S OF CORNEAL CYLINDER IF THE LID IS NOT LIFTED FOR MEASUREMENT. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 10935089

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other