BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK - IOL

    MDR report key: 1083572 · Received July 24, 2008

    Report

    Report Number
    1119421-2008-00542
    Event Type
    Other
    Date Received
    July 24, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 24, 2008
    Manufacturer
    ALCON RESEARCH, 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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION; THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDED A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A SURGEON REPORT THAT TWO YEARS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT REPORTED DECREASE VISUAL ACUITY. UPON SLIT-LAMP EXAMINATION, MANY SMALL YELLOW BUBBLE AND DISCOLORATION WERE NOTED IN BOTH LENSES. ADDITIONAL INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FIRST EYE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other