BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 3071830 · Received April 22, 2013

    Report

    Report Number
    2648035-2013-00195
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: 09/11/2015. DEVICE MANUFACTURE DATE: 09/11/2012. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). PRIOR TO RELEASE TO MARKET THE INTRAOCULAR LENS MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE SURGEON APPLIED GENTLE PRESSURE ON THE ANTERIOR ASPECT OF THE LENS DURING ASPIRATION OF THE PROVISC. IT WAS STATED THAT DURING THE APPLICATION OF GENTLE PRESSURE ON THE LENS, THE POSTERIOR CAPSULE RUPTURED. IT WAS STATED THAT THERE WERE NOT ANY CONSEQUENCES. THE IOL WAS IN THE BAG AND IT WAS STATED THAT THE PATIENT'S VISUAL ACUITY WAS 10/10 AT FIRST POST-OPERATIVE CONTROL 3 DAYS POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172634 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention