BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2103807 · Received May 18, 2011

    Report

    Report Number
    1119421-2011-00600
    Event Type
    Other
    Date Received
    May 18, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: 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. ROOT CAUSE: THE LOT/SERIAL NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE PRODUCT WAS NOT RETURNED AND NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A PATIENT IS BECOMING MYOPIC FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE REASON IS UNKNOWN; THE CORNEA AND MACULA ARE WITHOUT PATHOLOGICAL FINDINGS AND THE IOL "FITS REGULAR AND IS FIRMLY ATTACHED". THE IOL WAS NOTED TO HAVE MANY SMALL BROWNISH SPOTS, BUT THESE DO NOT AFFECT THE VISUAL ACUITY. 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 SN60AT NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other