BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2202055 · Received August 5, 2011

    Report

    Report Number
    1119421-2011-00950
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 6, 2011
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PRODUCT EVALUATION: LENS WAS RETURNED. NO DAMAGE OBSERVED. SOLUTION AND BLOOD ARE DRIED ON THE LENS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE RETURNED LENS PLAN VIEW DIMENSIONS WERE DEEMED ACCEPTABLE PER AN APPROVED TEMPLATE. ROOT CAUSE: THE ROOT CAUSE COULD BE DETERMINED FROM THE INVESTIGATION BECAUSE NO DAMAGE WAS OBSERVED; HOWEVER, THE EVENT WAS MOST LIKELY RELATED TO A FAILURE TO FOLLOW THE DFU. THE ACCOUNT INDICATED THAT THE COMPLAINT LENS WAS USED IN A PIGGYBACK SITUATION WHICH IS AGAINST THE DFU. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. 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. ADDITIONAL INFORMATION WAS REQUESTED VIA PHONE ON 07/14/2011; VIA MAIL ON 07/18/2011; VIA FAX ON 07/18/2011. A COMPLETED QUESTIONNAIRE HAS BEEN RECEIVED FROM THE SURGEON ON 07/26/2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WHO EXPERIENCED DECREASED VISION, PIGMENT DISPERSION AND THE IOL MOVED FORWARD IN THE EYE CAUSING A CHANGE IN REFRACTION FOLLOWING PIGGYBACK INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HE STATED HE EXPLANTED THE IOL AND DID NOT IMPLANT A NEW PIGGYBACK IOL. HE REPORTED THE PATIENT'S SYMPTOMS HAVE RESOLVED AND HER VISION IS NOW 20/20 WITHOUT CORRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH LTD. / HUNTINGTON MN60MA 11060092

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention ACRYSOF SN60WF IOL IMPLANT OD 24.0 DIOPTER