BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - IOL

    MDR report key: 2081360 · Received April 22, 2011

    Report

    Report Number
    1119421-2011-00470
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: 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. ROOT CAUSE: NO SERIAL/LOT NUMBER OR SAMPLE WAS PROVIDED BY THE CUSTOMER. THE PRODUCT WAS NOT RETURNED AND NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, EIGHT PATIENTS HAVE GLISTENINGS ON THEIR LENSES. THERE HAS BEEN NO IMPACT ON VISUAL ACUITY OR VISUAL ACUITY FUNCTION. 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./HUNTINGTON NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1