BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK--IOL

    MDR report key: 1440711 · Received August 14, 2009

    Report

    Report Number
    1119421-2009-00790
    Event Type
    Other
    Date Received
    August 14, 2009
    Date of Event
    January 1, 2009
    Report Date
    July 17, 2009
    Manufacturer
    ALCON RESEARCH. LTD./ HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION; THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDED A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFO WAS REQUESTED ON 07/23/2009, 07/27/2009, 07/30/2009, 07/31/2009 AND 08/05/2009 BY FAX, MAIL AND PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 08/14/2009.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT FIVE YEARS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT REPORTED BLURRY VISION. THE PT'S VA DECREASED FROM 20/25 TO 20/26. UPON EXAMINATION OF THE LENS, THE SURGEON OBSERVED A LARGE AMOUNT OF GLISTENINGS. THE PT DOES HAVE POSTERIOR CAPSULAR OPACIFICATION (PCO) BUT THE SURGEON DOES NOT FEEL THIS IS A CONTRIBUTOR TO THE DECREASED VISUAL ACUITY. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK--IOL INTRAOCULAR LENS HQL ALCON RESEARCH. LTD./ HUNTINGTON NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other