BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 5437289 · Received February 15, 2016

    Report

    Report Number
    9614546-2016-00058
    Event Type
    Malfunction
    Date Received
    February 15, 2016
    Date of Event
    January 18, 2016
    Report Date
    April 8, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE STRING-LIKE SUBSTANCE WITH A MEDICAL QUICK ABSORBER (MQA) WAS SUBMITTED TO A CONTRACT LAB FOR ANALYSIS. MICROSCOPIC EXAMINATION OF THE MQA REVEALED NO ''FIBROUS'' OR ''STRINGLIKE'' DEBRIS WAS FOUND. THE SEALED PLASTIC BAG IN WHICH THE MQA ARRIVED WAS ALSO EXAMINED AND NO DEBRIS WAS LOCATED. THUS NO ANALYSIS OF THE SUBSTANCE WAS CONDUCTED. THE COMPLAINT COULD NOT BE CONFIRMED. MANUFACTURING RECORDS WERE REVIEWED AND THE LENS WAS MANUFACTURED ACCORDING TO SPECIFICATION. THERE WERE NO NON CONFORMANCES WITH RESPECT TO THE MANUFACTURING PROCESS. THERE ARE NO ASSOCIATED NONCONFORMITY REPORTS OR DEVIATIONS. THE COMPLAINT RELATED TEST IS THE COSMETIC INSPECTION PERFORMED AT FINAL INSPECTION. AT FINAL INSPECTION ALL PRODUCTS ARE SUBJECT TO COSMETIC INSPECTION PRIOR TO OPTICAL TESTING. THE IN-LINE OPTICAL INSPECTION DATA SHOWS THE LENS IS WITHIN POWER SPECIFICATION; HENCE THE LENS MEETS THE SPECIFIED COSMETIC REQUIREMENTS. A SEARCH ON COMPLAINTS REVEALED THAT NO OTHER COMPLAINTS FOR THIS ORDER NUMBER WERE RECEIVED TO DATE. THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. THE DFU INSTRUCTS THAT THE LENS SHOULD BE THOROUGHLY EXAMINED TO ENSURE PARTICLES HAVE NOT BECOME ATTACHED TO IT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON NOTICED A STRING-LIKE SUBSTANCE WAS ADHERED TO AN INTRAOCULAR LENS, MODEL ZMB00, UNDER A MICROSCOPE AFTER THE LENS WAS IMPLANTED. THE FOREIGN SUBSTANCE WAS REMOVED FROM THE PATIENT'S EYE. THE LENS REMAINS IMPLANTED AND NO PATIENT INJURY IS REPORTED. NO FURTHER INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94663 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1