BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 6839410 · Received September 1, 2017

    Report

    Report Number
    2648035-2017-01581
    Event Type
    Malfunction
    Date Received
    September 1, 2017
    Date of Event
    August 7, 2017
    Report Date
    September 1, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS REMAINS IMPLANTED. (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL, MODEL PCB00V THAT HAS A SIMILAR DEVICE, TECNIS 1-PIECE IOL MODEL PCB00 WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER PMA P980040. DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED FOR EVALUATION; HOWEVER, VIDEOS WERE PROVIDED. THE VIDEOS WERE REVIEWED. BASED ON THE VIDEOS, IN THE RIGHT SIDE OF THE LENS, SOMETHING APPEARED TO BE LIKE A FIBER. BASED ON THE VIDEOS, THE REPORTED COMPLAINT WAS CONFIRMED. HOWEVER, THE PCB00 WAS NOT RETURNED TO EVALUATE THE COMPONENTS ASSEMBLY IN ORDER TO CONFIRM OR VERIFY THE REPORTED CONTAMINATION. THEREFORE, IT CANNOT BE DETERMINED IF THE PARTICLE CAME FROM THE INSIDE OF THE PCB00 DEVICE OR BELONGED TO A DIFFERENT ENVIRONMENT. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORD COULD NOT BE REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. THE COMPLAINT HISTORY COULD NOT BE PERFORMED SINCE THE SERIAL NUMBER IS UNKNOWN. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU PROVIDE THE CUSTOMER WITH PROPER USAGE INSTRUCTIONS AND GUIDELINES. CONCLUSION: AS A RESULT OF THE INVESTIGATION, 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 JUST AFTER THE INSERTION OF THE INTRAOCULAR LENS (IOL), THE DOCTOR OBSERVED A WHITE SUBSTANCE ON THE ANTERIOR SURFACE OF THE OPTIC. IT WAS DIFFICULT TO REMOVE IT BY THE IRRIGATION/ASPIRATION (I/A) PROCEDURE DUE TO THE FACT IT WAS HARD. WHEN REMOVING IT BY I/A, THE DOCTOR FORCIBLY TRIED TO PULL IT OUT WHILE PUTTING IT INTO THE I/A TIP. THE DEBRIS WAS DROPPED BEHIND THE IRIS AND REMOVED BY I/A. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617175 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00V

    Patients

    Seq Age Sex Outcome Treatment
    1