BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2421346 · Received January 16, 2012

    Report

    Report Number
    1119421-2012-00051
    Event Type
    Injury
    Date Received
    January 16, 2012
    Date of Event
    January 1, 2011
    Report Date
    December 16, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED ON 12/21/2011 AND 01/03/2012 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED NOTING BROWN SPOTS ON AN INTRAOCULAR LENS (IOL) FOLLOWING IMPLANTATION. THE SURGEON PERFORMED A YAG LASER PROCEDURE TO TRY TO REMOVE THE BROWN DEPOSITS. 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention