BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 4192938 · Received October 22, 2014

    Report

    Report Number
    2648035-2014-00560
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 15, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN. GENDER/SEX: UNKNOWN. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RETURNED FOR EVALUATION. THE PLUNGER COMPONENT WAS OBSERVED IN THE FULLY ADVANCED POSITION TO THE READY POSITION INDICATOR LINE. THE PLUNGER WAS LOCKED. IT WAS OBSERVED THAT THE PLUNGER DID NOT PULL BACK. A RESIDUE OF VISCOELASTIC WAS OBSERVED FROM LOADING ZONE TO THE CARTRIDGE TIP. THE CARTRIDGE TIP WAS OBSERVED DENTED. THERE WAS NO LENS OBSERVED INSIDE THE PCB00. THE CARTRIDGE WAS OBSERVED IN THE CORRECT POSITION (FULLY ENGAGED INTO THE LOWER BODY OF THE PCB00 DEVICE). DURING VISUAL INSPECTION DRIED VISCOELASTIC RESIDUE WAS NOTED IN THE SAME CARTRIDGE LOCATION. BASED ON THE VISUAL AND FUNCTIONAL INSPECTION RESULTS FOR THE RETURNED PCB00 SAMPLE IT CAN BE CONCLUDED THAT THE PCB00 DELIVERY SYSTEM WAS CORRECTLY ASSEMBLED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORD REVIEW WAS PERFORMED AND SHOWED THAT ALL PROCESS OPERATIONS DOCUMENTED IN THE MANUFACTURING RECORD WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTIONS AND SPECIFICATIONS. ALL TEST RESULTS SHOWED A PASS DISPOSITION. NO DEVIATION OR NONCONFORMANCE (NCR) RELATED TO THE CUSTOMER CLAIM WAS GENERATED. A REVIEW OF THE PROCESS MANUFACTURING INSTRUCTIONS IN THE CHANGE CONTROL SYSTEM WAS DONE WHEN THIS PRODUCTION ORDER WAS MANUFACTURED AND DID NOT SHOW ANY CHANGE IN THE MANUFACTURING METHOD OR SPECIFICATIONS THAT COULD BE RELATED FOR THIS COMPLAINT TYPE. THE DOCUMENTATION SHOWS THAT THE PRODUCT MET MANUFACTURING RELEASE CRITERIA. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DURING THE INITIAL PROCEDURE DUE TO ''NO STOP ¿ MISS FIRED AT WRONG MOMENT'', AN UNCONTROLLED DELIVERY OF THE LENS. A REPLACEMENT LENS WAS IMPLANTED. THERE WAS NO PATIENT INJURY REPORTED; HOWEVER, AN INCISION ENLARGEMENT WAS REQUIRED. AS INSTRUCTED, THE USER PULLED BACK ON THE KNOB TO CHECK TO SEE IF THE NUT WAS LOCKED AND HAS BEEN USING THE PRODUCT FOR MORE THAN A YEAR. THE IOL WAS DELIVERED AND THEN REMOVED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673664 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention