BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1253139 · Received December 5, 2008

    Report

    Report Number
    1119421-2008-00990
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    March 1, 2006
    Report Date
    November 6, 2008
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED, PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED ON 11/12/2008, 11/21/2008 AND 11/26/2008 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (2006). EVERY TIME HE PLAYS GOLF, HIS VISON GETS FOGGY.THIS REPORT WAS MAILED TO FDA ON: 12/05/2008.

    Description of Event or Problem · 1

    IN A LITERATURE REPORT, A SURGEON REPORTED A PATIENT THAT EXPERIENCED PIGMENTARY DISPERSION SYNDROME FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE LENS WAS PLACED IN THE SULCUS. POSTOPERATIVELY, THE PATIENT'S PRE-EXISTING GLAUCOMA HAD PROGRESSED TO THE POINT THAT HE REQUIRED A TRABECULECTOMY. THE PATIENT WAS ALSO DIAGNOSED WITH CHRONIC UVEITIS AND EARLY MACULAR DEGENERATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SA60AT NI

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention