BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 4292184 · Received December 2, 2014

    Report

    Report Number
    2648035-2014-00635
    Event Type
    Injury
    Date Received
    December 2, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 12, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT AND EXPLANT DATES: NOT APPLICABLE AS THE DEVICE WAS NOT FULLY IMPLANTED NOR EXPLANTED. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). (B)(4). PMA 510(K): THIS DEVICE IS NOT MARKETED IN THE US. IT IS SAME SIMILAR TO A TECNIS 1 PIECE IOL (ZCB00) PMA P980040. THE MANUFACTURING RECORDS WERE REVIEWED. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTIONS SPECIFICATIONS. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO DEVIATION OR NON-CONFORMANCE (NCR) RELATED TO THE CUSTOMER CLAIM WAS GENERATED. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT WHILE ATTEMPTING TO IMPLANT A I-TEC PRE LOADED TECNIS INTRAOCULAR LENS (IOL) (PCB00 18.5) THE IOL ''SHOT OUT'', INJURED THE IRIS, CAUSED CONSIDERABLE BLEEDING WHICH EXTENDED THE SURGERY TIME AND CAUSED TRAUMA. THE REPORT INDICATED THE SURGEON HAD EXPERIENCE USING THE DEVICE AND THAT THE UNIT WAS CORRECTLY PRIMED WITH HEALON. THE DEVICE WAS MOVED TO THE FIRST MARK AND THEN TO THE SECOND WHERE THE AUDIBLE CLICK WAS HEARD. AS HE INSERTED THE CARTRDIGE IN THE EYE AND ROTATED THE PLUNGER, THE LENS HAS COME OUT IN AN UNCONTROLLED MANNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776777 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEALON