BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 3903345 · Received June 30, 2014

    Report

    Report Number
    2648035-2014-00322
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 6, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Removal / Correction Number
    Z-1123-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: A REVIEW OF THE MANUFACTURING RECORDS WAS CONDUCTED. MANUFACTURING CONTROLS: DURING THE DIOPTER INSPECTION THE LENSES ARE MEASURED 100% FOR DIOPTER POWER, RESOLUTION, AND ASTIGMATISM. LENSES THAT DO NOT MEET THE ACCEPTABLE MEASURE/RESOLUTION ARE REJECTED. THE INSPECTION DATA FOR THE DIOPTER POWER PROCESS AT THE MONOFOCAL BENCH WAS REVIEWED AND FOUND WITHIN SPECIFICATION. THE QUANTITY OF 114 LENSES IN THIS OPERATION FOR THIS PRODUCTION ORDER HAS ACCEPTABLE IOL POWER RESULTS. NO LENSES WERE REJECTED DUE TO DIOPTER OUT SPECIFICATIONS OR INCORRECT LENS POWER. AT THE FINAL INSPECTION PROCESS, THE LENSES ARE 100% CLEANED AND INSPECTED AT 10X MICROSCOPE MAGNIFICATION. ANY DEFECTS ON THE LENSES THAT DO NOT MEET THE CRITERIA SPECIFICATIONS ARE REJECTED. THE PRODUCTION ORDER DOCUMENTATION (QUANTITY PROCESS, OR REJECTS DUE TO DROP OR LOST LENSES) WAS EVALUATED AND THEY DID NOT SHOW ANY IRREGULARITY THROUGH THE PROCESS. AT PRINT PROOF OPERATION THERE WAS NO DISCREPANCY IDENTIFIED. THE LABELS INCLUDED THE DIOPTER, MODEL, SERIAL NUMBER AND EXPIRATION DATE ACCORDING TO THE PRINT PROOF PROCEDURE. THE CONTENT OF THE FILED COPY OF THE PACKAGING BOX LABEL WAS REVIEWED AND FOUND CORRECT. THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4) - EXPLANT OF LENS. THIS DEVICE FALLS WITHIN THE SCOPE OF RECALL NUMBER Z-1123-2014.ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT AS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DATE RECEIVED BY MANUFACTURER ON FOLLOW UP REPORT #1 WAS INADVERTENTLY NOT ENTERED. DATE WAS 07/21/2014. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE LENS WAS RETURNED FOR EVALUATION OF DIOPTER POWER. THE LENS WAS RECEIVED CUT INTO THREE PIECES SEPARATING THE HAPTICS FROM THE CENTRAL OPTIC BODY. THE CENTRAL PORTION OF THE LENS WAS OBSERVED TO CONTAIN SUFFICIENT LENS MATERIAL TO MAKE A DIOPTER POWER MEASUREMENT POSSIBLE. TESTING WAS COMPLETED USING CALIBRATED EQUIPMENT. TESTING FOR DIOPTER POWER WAS CONDUCTED THREE TIMES ON THIS LENS. THE LENS DIOPTER POWER WAS CORRECT FOR A 19.5 LABELED DIOPTER. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS HYOPEROPTIC DURING POST EXAM AFTER INPLANTATION OF A Z9002 19.5 DIOPTER INTRAOCULAR LENS. THE LENS WAS EXPLANTED APPROXIMATELY TEN (10) WEEKS POST IMPLANT. THERE WAS NO PATIENT INJURY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THE PATIENT''S PRE-OP BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/40. POST-OP THE BCVA WAS 20/20 CYCLOPLEGIC REFRACTION. THE EXPLANTED LENS WAS REPLACED WITH ANOTHER Z9002 OF A HIGHER DIOPTER (22.0). THE PATIENT''S OUTCOME IS INDICATED AS +1.00/0.75X 1.35.THIS IS A RECALL LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379859 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention