BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - IOL

    MDR report key: 4213060 · Received October 24, 2014

    Report

    Report Number
    1119421-2014-00849
    Event Type
    Injury
    Date Received
    October 24, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ALCON RESEARCH LTD / HUNTINGTON
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND 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. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NO ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. NO FURTHER INFORMATION IS EXPECTED. (B)(4).

    Description of Event or Problem · 1

    THE HEALTH AUTHORITY RECEIVED 38 REPORTS OF IMPLANTED INTRAOCULAR LENSES (IOLS) IN 25 PATIENTS WITH DEFECTS IN THE MATERIAL CREATING GLISTENINGS OR REFRACTIVE ANOMALIES IN THE MATRIX OF THE LENS. THE DEFECTS HAVE CREATED DISABLING GLARE EFFECTS. THIRTEEN O THE PATIENTS ARE BILATERALLY IMPLANTED; TWELVE OF THE PATIENTS ARE UNILATERALLY IMPLANTED. THIS PATIENT IS UNILATERALLY IMPLANTED. NO FURTHER INFORMATION IS EXPECTED. THERE ARE 38 REPORTS ASSOCIATED WITH THESE EVENTS; THIS IS THE 35TH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680055 UNK - IOL INTRAOCULAR LENS HQL ALCON RESEARCH LTD / HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability