BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 7170194 · Received January 5, 2018

    Report

    Report Number
    2648035-2018-00042
    Event Type
    Injury
    Date Received
    January 5, 2018
    Date of Event
    December 5, 2017
    Report Date
    January 5, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER WAS NOT PROVIDED. THE LENS WAS NOT PROVIDED. (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 PCB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. (B)(4). DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURING SITE. THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE VERIFIED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR NEEDED TO ENLARGE THE INCISION SITE GREATER THAN THE TYPICAL 2.4MM IN ORDER TO FIT A PCB00V INTRAOCULAR LENS (IOL) INTO THE PATIENT'S OPERATIVE EYE TO IMPLANT THE LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13639 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention