BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 4221401 · Received November 3, 2014

    Report

    Report Number
    2648035-2014-00582
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 10, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PCB00 TECNIS ITEC PRELOADED DELIVERY SYSTEM WITH ACRYLIC ONE PIECE LENS WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE SAMPLE WAS INSPECTED AT 10X MICROSCOPE MAGNIFICATION. THE VISUAL INSPECTION REVEALED A SCARCE AMOUNT OF VISCOELASTIC AT THE CARTRIDGE. THE PLUNGER COMPONENT WAS OBSERVED IN THE FULLY ADVANCED POSITION, AND THE PUSH ROD WAS ADHERED TO PART OF THE LENS. A LENS HAPTIC WAS STUCK AT THE CARTRIDGE TUBE AND VERIFIED TO BE DETACHED. THE CARTRIDGE WAS OBSERVED IN THE CORRECT POSITION (FULLY ENGAGED INTO LOWER BODY OF THE PCB00 DEVICE). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    PATIENT AGE/DATE OF BIRTH AND GENDER: ASKED BUT UNAVAILABLE (ASKU). (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, TECNIS ITEC PRELOADED 1-PIECE IOL, THAT IS SIMILAR TO A PRODUCT DISTRIBUTED IN THE US, TECNIS 1-PIECE IOL ¿ PMA# P980040. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION: YES. RETURNED TO MANUFACTURER ON : 11/26/2014. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED. 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'S REPORTED WAS GENERATED. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE AMO SALES REPRESENTATIVE THAT DURING THE IMPLANT PROCESS OF THE INTRAOCULAR LENS (IOL) INTO PATIENT'S CAPSULE BAG, PHYSICIAN NOTICED THAT ONE OF THE HAPTICS HAD BROKEN OFF AND REMAINED STUCK INSIDE THE CARTRIDGE DEVICE, WHILE THE REST OF THE LENS WAS IN THE EYE. LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS. REPLACEMENT LENS MODEL AND DIOPTER WAS NOT PROVIDED. ADDITIONALLY, IT WAS NOTED THAT INCISION WAS ENLARGED IN THE REMOVAL PROCESS. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT IS DOING OK. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701615 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention