BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2586983 · Received May 21, 2012

    Report

    Report Number
    1119421-2012-00660
    Event Type
    Injury
    Date Received
    May 21, 2012
    Date of Event
    January 1, 2012
    Report Date
    April 20, 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
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ONLY THE LENS CARTON WAS RETURNED. RESULTS FROM THE PRODUCT HISTORY RECORD 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 04/23/2012, 05/08/2012 AND 04/25/2012 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY THE IOL WAS EXCHANGED DUE TO IT ¿NOT WORKING PROPERLY¿. 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 SA60AT 12084846

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention