BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1063206 · Received June 19, 2008

    Report

    Report Number
    1119421-2008-00454
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 27, 2007
    Report Date
    May 20, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADD'L INFO WAS REQUESTED ON 06/11/2008 BY MAIL AND FAX. PT RECORDS WERE RECEIVED 06/09/2008. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 06/19/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTS HAVING A PT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE LENS WAS EXCHANGED, RESULTING IN A TEMPORARY IMPROVEMENT IN VISUAL ACUITY. A YAG LASER PROCEDURE WAS THEN PERFORMED, WHICH ALSO RESULTED IN A TEMPORARY IMPROVEMENT IN VISUAL ACUITY. ADD'L INFO HAS BEEN REQUESTED. 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 SN6AD3 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other