BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3914458 · Received July 3, 2014

    Report

    Report Number
    2648035-2014-00329
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 9, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE RETURNED SAMPLE WAS INSPECTED AT THE MANUFACTURING SITE UNDER MICROSCOPE MAGNIFICATION. THE LENS OPTIC WAS CUT INTO PIECES, MOST PROBABLY RELATED TO EXPLANT PROCESS. VISUAL INSPECTION REVEALED SURFACE RESIDUALS (FIBER/PARTICLE) ON THE LENS, WHICH IS COMPATIBLE WITH THE HANDLING OF THE LENS OUT OF A STERILE ENVIRONMENT. NO FURTHER INVESTIGATION WAS PERFORMED. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO DEVIATIONS OR NONCONFORMITIES. THE DOCUMENTATION SHOWED THAT ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD WERE IN COMPLIANCE WITH MANUFACTURING SPECIFICATIONS. ALL TEST RESULTS SHOWED A PASS CONDITION. A REVIEW OF THE MANUFACTURING PROCESS AND/OR MATERIALS SHOW THERE WERE NO CHANGES IN MANUFACTURING METHOD, INSPECTIONS OR SPECIFICATIONS ASSOCIATED WITH THIS PRODUCTION ORDER. PRODUCT MET MANUFACTURING CRITERIA PRIOR TO RELEASE. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REMOVAL AND REPLACEMENT OF AN INTRAOCULAR LENS (IOL), VITRECTOMY WAS PERFORMED. THERE WAS NO INCISION ENLARGEMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389328 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention