BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2161821 · Received July 8, 2011

    Report

    Report Number
    1119421-2011-00853
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 9, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS RETURNED FOR ANALYSIS; THE REPORTER COMPLAINT COULD NOT BE VERIFIED. THE PRODUCT WAS RETURNED AND DAMAGE WAS OBSERVED. BLOOD AND SOLUTION WAS DRIED ON THE LENS. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: WHILE WE ARE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MANUFACTURING RELATED. DUE TO THE PRESENCE OF BLOOD AND SURGICAL SOLUTION, THE DAMAGE IS POTENTIALLY RELATED TO CUSTOMER HANDLING. 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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 06/14/2011, 06/15/2011, AND 06/27/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED FOR THE SAME MODEL AND POWER IOL DUE TO THE PATIENT REPORTING HER VISION WAS NOT GOOD. IN A FOLLOW UP WITH THE REPORTING FACILITY, IT WAS REPORTED THAT THE SURGEON NOTED BUBBLES IN THE IOL DURING AN EXAMINATION FOLLOWING THE PATIENT'S REPORT OF HER VISION NOT BEING GOOD. IT WAS REPORTED THE PATIENT'S UCVA WAS 20/25 AND ALL SYMPTOMS HAD RESOLVED FOLLOWING THE EXCHANGE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./ HUNTINGTON SN60WF 12008351

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention