BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS OPTIBLUE 1-PIECE

    MDR report key: 5069791 · Received September 10, 2015

    Report

    Report Number
    2648035-2015-00787
    Event Type
    Injury
    Date Received
    September 10, 2015
    Date of Event
    June 12, 2015
    Report Date
    September 10, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXPLANT DATE: NOT APPLICABLE; LENS REMAINS IMPLANTED AT THE TIME OF SUBMITTING THE MDR. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, INTRAOCULAR LENS (IOL) MODEL NUMBER ZCB00V THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE UNITED STATES, IOL MODEL NO. ZCB00, WHICH FALLS UNDER PMA P980040. (B)(4): SECONDARY PROCEDURE PERFORMED TO PLACE HAPTIC IN THE CAPSULAR BAG ONE DAY POST OPERATIVELY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY AFTER THE OPERATION OF THE INTRAOCULAR LENS (IOL), ONE HAPTIC WAS PLACED OUT OF THE CAPSULAR BAG. IN FOLLOW-UP, IT WAS REPORTED THAT THE SURGEON IMPLANTED THE LENS IN THE CAPSULAR BAG AND THERE WAS NO PROBLEM WITH THE CAPSULE. THE SURGEON POSITIONED ONE HAPTIC IN THE CAPSULAR BAG ONE DAY AFTER THE OPERATION. THERE WERE NO REMOVAL AND REPLACEMENT CONDUCTED. THERE WAS NO VISUAL ACUITY PROBLEM. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599439 TECNIS OPTIBLUE 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention