BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK - IOL

    MDR report key: 1211489 · Received October 23, 2008

    Report

    Report Number
    1119421-2008-00832
    Event Type
    Other
    Date Received
    October 23, 2008
    Report Date
    September 23, 2008
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    HQL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT WAS MAILED TO FDA ON: 10/23/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED HAVING A PT WITH GLISTENINGS AND DECREASED VISUAL ACUITY FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION 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 Other