BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - IOL

    MDR report key: 2202100 · Received August 5, 2011

    Report

    Report Number
    1119421-2011-00964
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 7, 2011
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: 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 MFG DOCUMENTATION. ROOT CAUSE: NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME. NO LOT/SERIAL NUMBER OR SAMPLE WAS RETURNED BY THE CUSTOMER. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFO. CONCLUSION: BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND BASED ON THESE FINDINGS THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. ADD'L INFO WAS REQUESTED 07/07/2011 AND 07/08/2011 BY FAX, MAIL AND PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT APPROX 5% OF PTS IMPLANTED WITH THIS MFR'S BRAND OF INTRAOCULAR LENSES (IOLS) REPORT SEEING AN ARC OF LIGHT IN THE POSTOPERATIVE PERIOD. HE HAD NO PARTICULAR PT TO REPORT. NO FURTHER INFO IS EXPECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other