BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3221813 · Received July 9, 2013

    Report

    Report Number
    1119421-2013-00738
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THREE YEARS FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OPACITY OF THE LENS WAS NOTED. THE PT WAS REPORTING VISUAL LOSS WHICH THE SURGEON FELT WAS RELATED TO THE LENS OPACITY. THE SURGEON IS CONSIDERING EXCHANGING THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313778 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60AT 10950998

    Patients

    Seq Age Sex Outcome Treatment
    1