BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1344285 · Received March 13, 2009

    Report

    Report Number
    1119421-2009-00211
    Event Type
    Injury
    Date Received
    March 13, 2009
    Date of Event
    February 1, 2002
    Report Date
    February 12, 2009
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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. REFERENCE: IWASE T, TANAKA N. CASE REPORTS - ELEVATED INTRAOCULAR PRESSURE IN SECONDARY PIGGYBACK INTRAOCULAR LENS IMPLANTATION. J CATARACT REFRACT SURG 2005; 31:1821-1823. THIS REPORT WAS MAILED TO FDA ON: 03/13/2009. THE

    Description of Event or Problem · 1

    IN A LITERATURE REPORT, A SURGEON REPORTED A PATIENT WHO EXPERIENCED AN ELEVATED INTRAOCULAR PRESSURE (IOP) FOLLOWING A PIGGYBACK INTRAOCULAR LENS (IOL) IMPLANT SURGERY IN 2001. (THE INITIAL IOL, IMPLANTED IN 2000, HAD FIBROSED IN PLACE AND WAS NOT REMOVED). THE PATIENT WAS SATISFIED WITH THE RESULT OF THE PIGGYBACK IOL PROCEDURE. FOUR MONTHS LATER, THE IOP GRADUALLY INCREASED AND WAS PROLONGED DESPITE MEDICATIONS. ALSO, HEAVY TRABECULAR MESHWORK PIGMENTATION WAS OBSERVED. IN 2003, THE INITIAL AND PIGGYBACK IOLS WERE EXCHANGED AND A TRABECULOTOMY WAS PERFORMED. POSTOPERATIVELY, THE PATIENT WAS REPORTED TO HAVE BCVA OF 20/20 AND THE IOP WAS SUCCESSFULLY CONTROLLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON MA60MA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention LATONOPROST| ACETAZOLAMIDE| TIMOLOL