BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK -- IOL

    MDR report key: 1519595 · Received October 30, 2009

    Report

    Report Number
    1119421-2009-01035
    Event Type
    Injury
    Date Received
    October 30, 2009
    Date of Event
    January 1, 2009
    Report Date
    October 2, 2009
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    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. ADD'L INFO WAS REQUESTED ON 10/02/2009, 10/07/2009, 10/13/2009, AND 10/23/2009 BY PHONE, FAX, AND MAIL. THE SURGEON WAS UNWILLING TO COMPLETE THE FOLLOW UP QUESTIONNAIRE. THIS REPORT WAS MAILED TO FDA ON: 10/30/2009.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE NOTICED THAT IN BROWN EYED PATIENTS, ESPECIALLY THOSE WITH INFLAMMATION AND/OR WHILE USING THE LASER, WERE HAVING PIGMENTS DEPOSITS ON THE ANTERIOR SURFACE OF THE IOL. THE SURGEON ALSO REPORTED THE IRIS WAS FIBROSING TO THE IOL. THE SURGEON WAS UNWILLING TO COMPLETE THE FOLLOW UP QUESTIONNAIRE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention