BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1230195 · Received November 13, 2008

    Report

    Report Number
    1119421-2008-00901
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    December 1, 2005
    Report Date
    October 14, 2008
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 INFO HAS BEEN REQUESTED. BOUTBOUL S, LETAIEF I, LALLOUM F. PUECH M, BORDERIE V. LAROCHE L. (2008). PIGMENTARY GLAUCOMA SECONDARY TO IN-THE-BAG INTRAOCULAR LENS IMPLANTATION. J CATARACT REFRACT SURG. 2008 SEPT; 34: 1595-97. THIS REPORT WAS MAILED TO FDA ON: 11/13/2008.

    Description of Event or Problem · 1

    IN A JOURNAL ARTICLE, A SURGEON REPORTED HAVING A PT THAT DEVELOPED PIGMENTARY GLAUCOMA FOLLOWING IN-THE-BAG INTRAOCULAR LENS (IOL) IMPLANT SURGERY. FROM THE FOURTH DAY POSTOPERATIVELY, THE INTRAOCULAR PRESSURE (IOP) INCREASED AND WAS CONTROLLED WITH ANTIGLAUCOMA MEDICATIONS. THE VISUAL ACUITY REMAINED 20/20. TO CONTROL THE IOP, FILTERING SURGERY WAS PERFORMED IN 2006. AT THAT TIME, IT WAS ALSO DISCOVERED THAT THE POSTERIOR SURFACE OF THE IRIS WAS BEING RUBBED BY THE INFERIOR HAPTIC OF THE IOL, WHICH WAS IN THE BAG AND DEFORMED. THE HAPTIC WAS PUSHED DOWNWARD TO RESTORE IT TO ITS PROPER SHAPE. AFTER THE FILTERING SURGERY, THE PT'S VISUAL FUNCTION STABILIZED AND INTRAOCULAR PRESSURES REMAINED NORMAL WITHOUT MEDICATIONS. ADDITIONAL INFO 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 52 YR Required Intervention