BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3911202 · Received July 2, 2014

    Report

    Report Number
    9614546-2014-00169
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION (B)(4). THE RETURNED SAMPLE WAS INSPECTED AT THE MANUFACTURING SITE UNDER 12X MICROSCOPE MAGNIFICATION. THE LENS OPTIC WAS CUT IN TWO (2) PIECES, MOST PROBABLY RELATED TO EXPLANT PROCESS. VISUAL INSPECTION REVEALED LENS CAN BE IDENTIFIED AS TECNIS TORIC ACRYLIC 1-PIECE INTRAOCULAR LENS (IOL) BECAUSE OF THE PRESENCE OF MARKING HOLES. LENS OPTIC WAS DAMAGED. LENS WAS CONTAMINATED AS DUST PARTICLE WERE PRESENT, WHICH IS REPRESENTATIVE OF LENS BEING OUT OF STERILE ENVIRONMENT. DUE TO THE DAMAGED CONDITION OF THE LENS, NO FURTHER INVESTIGATION WAS POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO DEVIATIONS OR NONCONFORMITIES. THE DOCUMENTATION SHOWED THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THERE ARE NO ASSOCIATED NONCONFORMITY MATERIAL REPORTS WITH RESPECT TO THE ORDER NUMBER. REVIEW OF THE STERILIZATION RECORDS SHOWED NO NONCONFORMANCES. RESULTS OF ENVIRONMENTAL MONITORING RECORDS SHOWED NO NONCONFORMANCES FOR THE ASSOCIATED ORDER NUMBER. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO AMO SALES TERRITORY MANAGER THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT¿S LEFT EYE IN A SECONDARY PROCEDURE ATTRIBUTED TO OVERCORRECTION OF THE CYLINDER AND RESIDUAL MYOPIA. USE ERROR WAS REPORTED. IT WAS STATED THAT PRE-OPERATIVE CYLINDER WAS 1.86 X 102 AND UNCORRECTED DVA (DISTANCE VISUAL ACUITY) WAS 20/60-. AT THREE WEEK POST-OPERATIVE VISIT, REFRACTION WAS -1.00 +1.00 X 014. THE EXPLANTED LENS WAS REPLACED WITH A ZCT225 23.D DIOPTER LENS. IN ADDITION, THERE WERE NO PATIENT COMPLICATIONS REPORTED. NO INCISION ENLARGEMENT AND NO VITRECTOMY WERE REPORTED. THE PATIENT WAS REPORTED TO HAVE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385851 TECNIS TORIC IOLS HQL ABBOTT MEDICAL OPTICS ZCT300

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention