BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK -- IOL

    MDR report key: 1104906 · Received August 8, 2008

    Report

    Report Number
    1119421-2008-00581
    Event Type
    Other
    Date Received
    August 8, 2008
    Date of Event
    January 1, 2007
    Report Date
    July 9, 2008
    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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVAL; THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFO WAS REQUESTED 07/15/2008, 07/16/2008, 07/18/2008, 07/21/2008, 07/23/2008 AND 08/04/2008 BY PHONE. THE CONSUMER HAS NOT RETURNED ANY CALLS OR PROVIDED THE NAME OF THE IMPLANTING SURGEON.

    Description of Event or Problem · 1

    A CONSUMER REPORTS THAT FOUR MONTHS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HER VISION BECAME BLURRY AND HAD A BROWN TINT. HER SURGEON TOLD HER IT WAS DUE TO SCARRING. ONE AND A HALF YEARS FOLLOWING THE SURGERY, HER VISION IS STILL "LIKE LOOKING THROUGH A DIRTY WINDOW". 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 UNK NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other