BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1290896 · Received December 5, 2008

    Report

    Report Number
    1119421-2008-00993
    Event Type
    Other
    Date Received
    December 5, 2008
    Date of Event
    October 24, 2008
    Report Date
    November 6, 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
    CA, 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 INFORMATION WAS REQUESTED ON 01/10/2008, 11/11/2008, AND 11/25/2008 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 12/01/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WHO DEVELOPED PIGMENT DISPERSION AND PIGMENTARY OPEN-ANGLE GLAUCOMA FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. INTRAOCULAR PRESSURE (IOP) WAS ELEVATED AND NOW BEING CONTROLLED WITH MEDICATION. THE IOL IMPLANT SURGERY WAS PERFORMED IN 2003 BY ANOTHER SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SA60AT 788916

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other