BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1696288 · Received May 20, 2010

    Report

    Report Number
    1119421-2010-00603
    Event Type
    Injury
    Date Received
    May 20, 2010
    Date of Event
    June 1, 2007
    Report Date
    April 20, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFO WAS REQUESTED ON 04/20/2010, 04/22/2010, AND 05/10/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. KUO I, MYROWITZ E, CHUCK R, SCHEIN O. WAVEFRONT-GUIDED PHOTOREFRACTIVE KERATECTOMY TO CORRECT AMETROPIA FOLLOWING ASPHERIC RESTOR IMPLANTATION. J REFRACT SURG, 2009:25; 1111-1115." (B) (4). (B) (4). (B) (4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "AMETROPIA" (POSTOPERATIVE REFRACTION, UNEXPECTED). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFORMATION [IOL (INTRAOCULAR LENS) IMPLANT]. IN A JOURNAL ARTICLE, A SURGEON REPORTED TWO PTS (THREE EYES) WITH AMETROPIA FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. PHOTOREFRACTIVE KERATECTOMY (PRK) WAS PERFORMED ON BOTH PTS TO CORRECT THE REFRACTIVE ERROR AND TO ATTAIN BETTER UCVA. IT WAS REPORTED IN THE ARTICLE THAT, POST-PRK, BOTH PTS HAVE IMPROVED UCVA. ADDITIONAL INFO HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT; THIS REPORT IS FOR THE SECOND PT, RIGHT EYE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention