BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1542494 · Received November 19, 2009

    Report

    Report Number
    1119421-2009-01105
    Event Type
    Injury
    Date Received
    November 19, 2009
    Date of Event
    February 1, 2009
    Report Date
    October 20, 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
    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 INFO WAS REQUESTED ON 10/20/2009, 10/26/2009, 10/29/2009, 11/09/2009, AND 11/16/2009 BY PHONE, FAX, AND MAIL. THE SURGEON WAS UNWILLING TO COMPLETE THE QUESTIONNAIRE. (DEVICE, INCORRECT CARE/USE OF). THIS REPORT WAS MAILED TO FDA ON: 11/19/2009.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PT SAT UP DURING SURGERY, RESULTING IN A CAPSULAR BAG TEAR. THE IOL WAS PLACED IN THE SULCUS DUE TO THE CAPSULAR BAG TEAR. POSTOPERATIVELY, THE PT WAS NOTED TO HAVE PIGMENTARY DISPERSION, IRITIS, AND ELEVATED INTRAOCULAR PRESSURE (IOP). A SECONDARY SURGICAL PROCEDURE WAS PERFORMED TO INSERT A GLAUCOMA VALVE TO RELIEVE THE ELEVATED IOP. FOLLOWING THIS PROCEDURE, THE PT'S VISUAL ACUITY WAS NOTED TO BE UCVA 20/20 AND THE IOP WAS UNDER CONTROL. THE SURGEON REPORTED THE PT IS ALSO BEING TREATED WITH MEDICATIONS. THE SURGEON WAS UNWILLING TO COMPLETE THE QUESTIONNAIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON MA60AC 10863541

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention