BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - IOL

    MDR report key: 1514086 · Received October 21, 2009

    Report

    Report Number
    1119421-2009-00998
    Event Type
    Injury
    Date Received
    October 21, 2009
    Date of Event
    May 1, 2009
    Report Date
    July 9, 2009
    Manufacturer
    ALCON MANUFACTURING, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; DEVICE REMAINS IMPLANTED. 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 09/24/2009, 10/08/2009, 10/12/2009, AND 10/19/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 10/21/2009.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE NOTED FOREIGN MATERIAL IN THE PT'S EYE THAT IS CAUSING INFLAMMATION WITH MILD CELL / FLARE, PAIN, UVEITIS AND PHOTOPHOBIA. THE PT WAS TREATED WITH MEDICATION AND AN ANTERIOR CHAMBER WASH. ADD'L INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TORSIONAL PHACO HANDPIECE| SILICONE TIP