BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1404129 · Received June 18, 2009

    Report

    Report Number
    1119421-2009-00577
    Event Type
    Other
    Date Received
    June 18, 2009
    Date of Event
    June 1, 2009
    Report Date
    May 19, 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
    TX, 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 05/19/2009, 05/21/2009, AND 06/03/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTED TWO PATIENTS WITH UNEXPECTED POSTOPERATIVE REFRACTIONS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FIRST PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH LTD / HUNTINGTON SN6AD1 10876142

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other