BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS OPTIBLUE 1-PIECE

    MDR report key: 6187371 · Received December 19, 2016

    Report

    Report Number
    2648035-2016-02063
    Event Type
    Injury
    Date Received
    December 19, 2016
    Date of Event
    October 17, 2016
    Report Date
    January 22, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474546806
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS REMAINS IMPLANTED. (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE 1-PIECE IOL, THAT HAS A SIMILAR DEVICE, TECNIS 1-PIECE IOL MODEL ZCB00 WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER PMA P980040. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL EVALUATION COULD NOT BE PERFORMED, THEREFORE THE REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORDS WERE REVIEWED AND THE LENS WAS MANUFACTURED ACCORDING TO SPECIFICATION. THE COMPLAINT HISTORY SEARCH REVEALED NO OTHER COMPLAINTS FOR THIS PRODUCTION ORDER NUMBER HAS BEEN RECEIVED. THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE INTRAOCULAR LENSES. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANTATION OF A ZCB00V INTRAOCULAR LENS, THE PATIENT EXPERIENCED AN NON-BACTERIAL INFLAMMATION ON HIS EYE. THE PHYSICIAN PRESCRIBED STEROIDS FOR THE INFLAMMATION. ADDITIONALLY, THE PATIENT HAD VISUAL ACUITY ISSUES AND WAS AT 0.1 (2/20).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837820 TECNIS OPTIBLUE 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00V 05050474546806

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention