BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 4140758 · Received October 3, 2014

    Report

    Report Number
    2648035-2014-00521
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    July 2, 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

    ADDITIONAL INFO: THE INTRAOCULAR LENS WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RETURNED SAMPLE WAS INSPECTED AT 10X MICROSCOPE MAGNIFICATION. VISUAL INSPECTION REVEALED THAT LENS WAS RECEIVED CUT IN HALF. VISUAL INSPECTION ALSO REVEALED SURFACE RESIDUALS ON THE LENS. THE LENS CONDITION IS CONSISTENT WITH A LENS THAT WAS EXPLANTED FROM THE PATIENT¿S EYE. THE INSPECTION DATA IN THIS PRODUCTION ORDER FOR THE DIOPTER POWER AT THE MONOFOCAL BENCH WAS REVIEWED AND WAS FOUND WITHIN SPECIFICATION. CORRECTED DATA: THE FOLLOWING CODES WERE OMITTED FROM MDR FOLLOW-UP 1 FOR THE MANUFACTURING RECORD REVIEW: ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORD REVIEW INDICATED THAT ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD 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 INSPECTION DATA FOR THE DIOPTER POWER PROCESS AT THE MONOFOCAL BENCH WAS REVIEWED AND WAS FOUND WITHIN SPECIFICATION. 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. THE MANUFACTURING RECORD REVIEW INDICATED THAT 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 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE, IN A SECONDARY PROCEDURE, DUE TO UNEXPECTED POST-OPERATIVE REFRACTION WITH MYOPIC OUTCOME. NO INCISION ENLARGEMENT OCCURRED AND VITRECTOMY WAS NOT PERFORMED. A REPLACEMENT LENS WAS PLACED. THE REPLACEMENT LENS WAS OF THE SAME MODEL BUT DIFFERENT DIOPTER (Z9002 DIOPTER 21.0), SERIAL NUMBER (B)(4). PATIENT WAS REPORTED TO BE DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620012 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention