BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2593462 · Received May 25, 2012

    Report

    Report Number
    1119421-2012-00695
    Event Type
    Injury
    Date Received
    May 25, 2012
    Date of Event
    April 26, 2012
    Report Date
    April 26, 2012
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD¿L INFO WAS REQUESTED ON 04/27/2012 AND 05/18/2012 BY PHONE, FAX, AND MAIL. A COMPLETED QUALITY QUESTIONNAIRE WAS RECEIVED ON 05/16/2012. A COMPLETED FOLLOW UP QUESTIONNAIRE HAS NOT BEEN RECEIVED. ADD¿L INFO WAS RECEIVED IN A FOLLOW UP PHONE CALL ON 05/18/2012. (B)(4).

    Description of Event or Problem · 1

    A MATERIALS MANAGER REPORTED AN INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DURING THE SAME SURGICAL PROCEDURE. INFO WAS RECEIVED FROM A NURSE THAT THE LENS WAS REMOVED DURING THE CASE BECAUSE THE ¿SURGEON OPTED TO REMOVE THE LENS¿ DUE TO OTHER ISSUES DURING THE PROCEDURE. ADD¿L INFO WAS RECEIVED FROM THE RISK MANAGER FOR THE SURGEON THAT A LINEAR POSTERIOR CAPSULE TEAR WAS NOTED AFTER THE LENS WAS INSERTED. ADD¿L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH LTD/HUNTINGTON SN60WF 12091507

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention