BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 4401152 · Received January 8, 2015

    Report

    Report Number
    2648035-2015-00003
    Event Type
    Injury
    Date Received
    January 8, 2015
    Date of Event
    December 18, 2014
    Report Date
    December 18, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FEMALE, (B)(6) YEARS OLD. THE TECNIS 1 PIECE INTRAOCULAR LENS 21.5 DIOPTER, WAS SHIFTED TO A COMPETITOR'S MULTI-PIECE INTRAOCULAR LENS. THE IOL WAS FIXED IN THE SULCUS. CATALOG #: 21.5 DIOPTER. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE ONLY IDENTIFIED AS TECNIS 1 PIECE. HAVE CHOSEN HQL-MONOFOCAL AS A DEFAULT. SERIAL NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. INITIAL REPORTER: ADDRESS AND PHONE NUMBER NOT PROVIDED. CONCOMITANT PRODUCT: PLATINUM 2.2 INSERTER AND PLATINUM UNFOLDED CARTRIDGE. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT DURING THE IMPLANTATION OF A TECNIS 1 PIECE INTRAOCULAR LENS (IOL) THE CAPSULAR BAG WAS DAMAGED DUE TO PLATINUM 2.2 INJECTOR'S SUDDEN JERK MOVEMENT. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15875 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS TECNIS 1 PIECE

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention