BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 4140736 · Received October 3, 2014

    Report

    Report Number
    2648035-2014-00520
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    July 23, 2014
    Report Date
    September 10, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INTRAOCULAR LENS WAS VISUALLY INSPECTED UNDER A MICROSCOPE. VISUAL INSPECTION REVEALED THAT THE LENS WAS RETURNED CUT IN TWO PIECES. SURFACE RESIDUALS (FIBER/PARTICLES) WERE OBSERVED ON THE LENS. THE LENS WAS RETURNED WITH ONE OF THE HAPTICS DISTORTED. THE LENS CONDITION IS CONSISTENT WITH A LENS THAT WAS EXPLANTED FROM THE PATIENT¿S EYE. DUE TO THE CONDITION OF THE SAMPLE RETURNED THE DIOPTER MEASUREMENT COULD NOT BE PERFORMED. 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 WAS REVIEWED AND SHOWED THAT ALL PROCESS OPERATIONS PRESENTED FROM MOLDING TO BOXING WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTION SPECIFICATIONS. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO DEVIATION OR NON-CONFORMANCE (NCR) WAS GENERATED WHEN THIS PRODUCTION ORDER WAS MANUFACTURED. THE MANUFACTURING RECORD WAS REVIEWED AND THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND NO DEVIATION OR ASSIGNABLE CAUSE WAS IDENTIFIED WHEN THIS PRODUCTION ORDER WAS MANUFACTURED. BASED ON THE INVESTIGATION, THE PRODUCT MET MANUFACTURING RELEASE CRITERIA. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENS WAS EXPLANTED FROM THE PATIENT'S LEFT EYE IN A SECONDARY PROCEDURE DUE TO A MYOPIC OUTCOME AFTER THE LENS WAS IMPLANTED. IT WAS STATED THAT THERE WAS NO USE ERROR, THE INCISION WAS NOT ENLARGED AND A VITRECTOMY WAS NOT PERFORMED. NO PATIENT INJURY WAS REPORTED. IT WAS REPORTED THAT THE PATIENT'S VISUAL OUTCOME IS EXCELLENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619898 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention