BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARRAY

    MDR report key: 2111791 · Received June 2, 2011

    Report

    Report Number
    2648035-2011-00098
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 4, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P960028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED INTRAOCULAR LENS WAS INSPECTED AT 10X MAGNIFICATION AND SHOWS AN OPTIC CUT IN 2 PIECES. VISUAL INSPECTION SHOWED NO COSMETIC OR DIMENSIONAL DEFECT. THE LENS WAS INSPECTED FOR HAZE AND CONFIRMED TO BE WITHIN PRODUCT SPECIFICATION. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED FOR ANALYSIS. HALOS AND GLARE ARE A KNOWN AND LABELED POSSIBLE SIDE EFFECT OF ALL MULTIFOCAL LENS IMPLANTS. ALL INFORMATION CURRENTLY AVAILABLE IS INCLUDED IN THIS REPORT. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. OTHER: THE PRODUCT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED EXPLANTING A MULTIFOCAL INTRAOCULAR LENS (B)(6) POST IMPLANT WITHOUT COMPLICATION OR INJURY DUE TO PATIENT DISSATISFACTION WITH HALOS AND GLARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARRAY MULTIFOCAL INTRAOCULAR LENS MFK ABBOTT MEDICAL OPTICS SA40N

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention