BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK - IOL

    MDR report key: 2093675 · Received April 20, 2011

    Report

    Report Number
    1119421-2011-00448
    Event Type
    Other
    Date Received
    April 20, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 21, 2011
    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
    BE
    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 LOT/SERIAL NUMBER OR SAMPLE WAS RETURNED BY THE CUSTOMER. NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. ADDITIONAL INFORMATION WAS REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED HAVING A PATIENT WITH A DISCOLORED INTRAOCULAR LENS (IOL) THAT WAS IMPLANTED TEN YEARS AGO. THERE IS A SLIGHT DECREASE IN VISION UNILATERALLY, BUT THE PATIENT HAS NOT REPORTED ANY COMPLAINTS. 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 Other