BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2041906 · Received March 30, 2011

    Report

    Report Number
    1119421-2011-00356
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    January 10, 2011
    Report Date
    February 28, 2011
    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
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. NO SAMPLE WAS RETURNED. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 03/01/2011, 03/08/2011, 03/11/2011, AND 03/23/2011 BY PHONE, FAX, AND MAIL. ADDITIONAL INFO WAS OBTAINED BY PHONE ON 03/02/2011. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED. IN A FOLLOW-UP, THE NURSE EXPLAINED THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE WHEN THE "CAPSULE WAS COMPROMISED". HE REPORTED THAT THE PT DID NOT EXPERIENCE DOCUMENTED COMPLICATIONS. ADDITIONAL 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 10936127

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other