BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1212606 · Received October 24, 2008

    Report

    Report Number
    1119421-2008-00829
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    May 15, 2008
    Report Date
    September 24, 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
    FL, 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 BY FAX AND MAIL ON 09/26/08 AND BY PHONE ON 10/09/08. INFORMATION WAS REC'D ON 09/26/08 BY PHONE. A COMPLETED QUESTIONNAIRES WERE REC'D. THIS REPORT WAS MAILED TO FDA ON: 10/24/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTS A PT EXPERIENCING PIGMENTARY GLAUCOMA FOLLOWING PIGGYBACK INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTS THE IOL IS RUBBING ON THE POSTERIOR IRIS SURFACE CAUSING ELEVATED INTRAOCULAR PRESSURES AND IRIS PIGMENT TO FLOAT IN THE ANTERIOR CHAMBER. THE SURGEON FURTHER REPORTS THE PT HAS BEEN TREATED WITH A YAG LASER IRIDOTOMY AND MEDICATIONS. IN A FOLLOW UP, THE SURGEON REPORTS THE OUTCOME OF THE EVENT AND PROGNOSIS AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON MN60MA 10775830

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention PROVISC