BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 3904787 · Received May 28, 2014

    Report

    Report Number
    1119421-2014-00397
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. PRESENTATION GIVEN A PROFESSIONAL MEETING (B)(4) 2014. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    DURING A PROFESSIONAL MEETING, A SURGEON GAVE A PRESENTATION ON GLISTENINGS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314866 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1