BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2143014 · Received June 23, 2011

    Report

    Report Number
    1119421-2011-00789
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 18, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. THE SAMPLE WAS NOT RETURNED. 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 05/27/2011 AND 06/13/2011 BY FAX, MAIL AND PHONE. A COMPLETED QUALITY QUESTIONNAIRE WAS RECEIVED 05/24/2011. A COMPLETED FOLLOW UP QUESTIONNAIRE WAS RECEIVED 06/21/2011. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS CRACKED AND REMOVED FROM A PATIENT'S EYE. IN A FOLLOW UP, A NURSE REPORTED THAT THE INCISION WAS ENLARGED TO REMOVE THE LENS AND "MAY HAVE CONTRIBUTED TO HAVING TO PERFORM A VITRECTOMY." FOLLOW UP INFORMATION WAS RECEIVED FROM THE SURGEON. THE PATIENT HAS A HISTORY OF PSEUDOEXFOLIATION, AND REMOVAL OF THE CRACKED LENS CAUSED THE ZONULES TO DEHISCE WHICH WARRANTED PLACEMENT OF AN ANTERIOR CHAMBER LENS. THE SURGEON REPORTED THE EVENT RESOLVED WITHOUT TREATMENT. AN UNAPPROVED VISCOELASTIC WAS USED DURING THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH LTD. / HUNTINGTON MA60AC 12012621

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention HEALON