BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 4282396 · Received November 26, 2014

    Report

    Report Number
    2648035-2014-00632
    Event Type
    Injury
    Date Received
    November 26, 2014
    Date of Event
    November 6, 2014
    Report Date
    November 7, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER. THE PLUNGER COMPONENT WAS OBSERVED IN FULLY ADVANCE POSITION UNTIL THE READY POSITION INDICATOR LINE. THE PLUNGER WAS LOCKED. THE PLUNGER DOES NOT PULL BACK. A RESIDUE OF VISCOELASTIC WAS OBSERVED FROM LOADING ZONE TO THE CARTRIDGE TIP. THERE WERE SLIGHTLY STRETCH MARKS ON THE CARTRIDGE TUBE COMPATIBLE WITH THE LENS DELIVERY. THERE WAS NO LENS OBSERVED INSIDE THE PCB00. CARTRIDGE WAS OBSERVED IN THE CORRECT POSITION (FULLY ENGAGED INTO LOWER BODY OF THE PCB00 DEVICE). MANUFACTURING RELATED CAUSE WAS NOT IDENTIFIED. FUNCTIONAL TEST: THIS IS A SINGLE USE UNIT THEREFORE FUNCTIONAL TEST WAS CONDUCTED PER ENGINEERING TEST (ET) (B)(4) AS INFORMATION ONLY. ACCEPTABLE RE-DELIVERY RESULTS USING THE MARKET RETURNED PCB00 SAMPLE WITH NEW LENS WITH THE SAME DIOPTER WAS OBTAINED AS PART OF THE FUNCTIONAL TEST. IN ADDITION A DYE TEST WAS PERFORMED TO THE CARTRIDGE. DYE TEST RESULTS SHOW OVERALL COATING PRESENCE WITH LESS DYE INTENSITY IN THE TRANSITION AREA, WHERE THE DIAMETER IS REDUCED, AND PRIOR TO THE TIP SECTION. THIS IS A TYPICAL RESULT OF A CARTRIDGE THAT WAS USED FOR LENS DELIVERY. BASED ON THE VISUAL INSPECTION RESULTS FOR THE RETURNED PCB00 SAMPLE IT CAN BE CONCLUDED THAT THE PCB00 WAS CORRECTLY ASSEMBLED. THE PLUNGER COMPONENT WAS OBSERVED IN FULLY ADVANCE POSITION UNTIL THE READY POSITION INDICATOR LINE. THE PLUNGER DOES NOT PULL BACK THEREFORE THE PLUNGER WAS PROPERLY LOCKED. THE COMPLAINT TYPE ¿PRELOADED PLUNGER DID NOT LOCK¿ WAS NOT VERIFIED. IN ADDITION THE COMPLAINT TYPE ¿UNCONTROLLED DELIVERY¿ WAS NOT CONFIRMED BASED ON ACCEPTABLE RE-DELIVERY RESULTS USING THE RETURNED PCB00 AND A NEW LENS WITH THE SAME DIOPTER AS PART OF THE ENGINEERING TEST (ET) (B)(4) FOR THE FUNCTIONAL TEST. ENGINEERING TEST (ET) (B)(4) WAS CONDUCTED AS INFORMATION ONLY. THE PRODUCT MEETS THE ACCEPTANCE CRITERIA. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: A REVIEW OF THE MANUFACTURING RECORDS WAS CONDUCTED. RESULTS REVEALED ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTION SPECIFICATIONS. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO DEVIATION OR NON-CONFORMANCE (NCR) RELATED TO THE CUSTOMER CLAIM WAS GENERATED. THERE WERE NO PROCESS CONTROLS AND/OR MATERIAL CHANGES DURING THE PERIOD WHEN THIS PRODUCTION ORDER (P/O) WAS MANUFACTURED AND RECORDS DO NOT SHOW ANY CHANGE IN THE MANUFACTURING METHOD OR SPECIFICATIONS THAT COULD BE RELATED FOR THIS COMPLAINT TYPE. NO OTHER INVESTIGATIONS REQUESTS HAVE BEEN RECEIVED FOR THIS P/O. THERE IS NO ADVERSE TREND THAT REQUIRES FURTHER INVESTIGATION FOR THE COMPLAINT TYPE REPORTED. THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THE PRODUCT MET MANUFACTURING RELEASE CRITERIA. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #2 - DEVICE EVALUATED BY MFR SHOULD HAVE BEEN CHECKED YES. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS NOT MARKETED IN THE USA. IT IS SAME/SIMILAR TO TECNIS ONE-PIECE IOL; PMA P980040. 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 ITEC PRELOADED INTRAOCULAR LENS (IOL) THE DEVICE REPORTEDLY CAME OUT OF THE CARTRIDGE IN AN UNCONTROLLED MANNER AND DAMAGED THE IRIS WHICH CAUSED BLEEDING. THE INCISION WAS ENLARGED TO REMOVED THE IOL FROM THE EYE. THE PATIENT WAS TREATED WITH DIAMOX. THE REPORT INDICATED THAT PRIOR TO INSERTING THE DEVICE IN THE EYE, THE LENS WAS PREPARED FOR DELIVERY THE PLUNGER DID NOT ENGAGE. A SECOND ATTEMPT WAS MADE UNTIL THE PLUNGER LOCKED. ONCE LOCKED THE PUSHROD MOVED BUT THE LENS MIGRATION WAS STIFF. THE LENS EVENTUALLY CAME OUT BUT AS PREVIOUSLY NOTED, IN AN UNCONTROLLED MANNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768716 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention