BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1344283 · Received March 13, 2009

    Report

    Report Number
    1119421-2009-00214
    Event Type
    Injury
    Date Received
    March 13, 2009
    Date of Event
    October 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. SEE SCANNED PAGES.

    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 2002. THE PATIENT WAS SATISFIED WITH THE RESULT OF THE SURGERY. POSTOPERATIVELY, THE IOP CONTINUED TO INCREASE AND WAS PROLONGED DESPITE MEDICATIONS; AND A PUPILLARY BLOCK OCCURRED FOLLOWING DILATION FIVE MONTHS AFTER THE SURGERY. HEAVY TRABECULAR MESHWORK PIGMENTATION WAS ALSO OBSERVED. THE ORIGINAL AND PIGGYBACK IOLS WERE EXCHANGED AND A TRABECULOTOMY WAS PERFORMED.

    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 68 YR Required Intervention LATANOPROST| GLYCERIN| TIMOLOL| PILOCARPINE