BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2231179 · Received August 26, 2011

    Report

    Report Number
    1119421-2011-01053
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE 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: THE ROOT CAUSE CANNOT BE DETERMINED. NO ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. NO FURTHER ACTION IS WARRANTED AT THIS TIME. 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. THE SURGEON COULD NOT BE CONTACTED FOR FOLLOW UP. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED HAVING A PATIENT WITH A REFRACTIVE SURPRISE FOLLOWING INTRAOCULAR LEN (IOL) IMPLANT SURGERY. THE SURGEON COULD NOT BE CONTACTED FOR FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other