BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - IOL

    MDR report key: 1031445 · Received April 18, 2008

    Report

    Report Number
    1119421-2008-00256
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 21, 2008
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    HQL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. ADDITIONAL INFO REQUESTED ON 03/26/2008, 04/03/2008 AND 04/07/2008 BY PHONE, ON 03/27/2008, 04/03/2008, 04/11/2008 BY MAIL AND ON 04/11/2008 BY FAX. THIS REPORT WAS MAILED TO FDA ON: 04/18/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED GLISTENINGS ON THE INTRAOCULAR LENS (IOL). 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. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI