BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 4223588 · Received November 4, 2014

    Report

    Report Number
    9614546-2014-00261
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 23, 2014
    Report Date
    October 23, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE LENS OPTIC WAS RETURNED CUT IN PIECES, WHEREBY DUST PARTICLES WERE PRESENT. THE LENS CONDITION WAS CONSISTENT WITH A LENS THAT WAS EXPLANTED FROM THE PATIENT¿S EYE. VISUAL INSPECTION REVEALED THAT AN INCOMPLETE DEVICE WAS RETURNED WHEREBY ONE HALF OF THE LENS WAS PRESENT. VISUAL INSPECTION USING A MICROSCOPE AT (B)(4) MAGNIFICATION SHOWED THAT THE LENS CAN BE IDENTIFIED AS TECNIS TORIC ACRYLIC 1-PIECE INTRAOCULAR LENS BECAUSE OF THE TYPE OF HAPTICS AND THE PRESENCE OF MARKING HOLES. DUE TO THE CONDITION OF THE LENS ADDITIONAL ANALYSIS IS NOT POSSIBLE. THE MANUFACTURING RECORD REVIEW WAS PERFORMED. THE PRODUCTION ORDER WAS NOT PRODUCED UNDER DEVIATION. THERE WERE NO PROCESS AND / OR MATERIAL CHANGES WITHIN THE PRODUCTION ORDER MANUFACTURING. THERE WERE NO NON CONFORMANCES WITH RESPECT TO THE STERILIZATION PROCESS. THE COMPLAINT RELATED ASSOCIATED TEST IS THE OPTICAL MEASUREMENT PERFORMED AT FINAL INSPECTION. THE IN-LINE OPTICAL INSPECTION DATA SHOWED THE LENS WAS WITHIN SPECIFICATION IN TERMS OF OPTICAL AND CYLINDER POWER. THERE WERE NO ENVIRONMENTAL MONITORING RELATED NONCONFORMANCES WITHIN THE TIMEFRAME WHEN THE PRODUCTION ORDER WAS MANUFACTURED. THERE WERE NO ASSOCIATED NONCONFORMITY MATERIAL REPORTS OR NONCONFORMANCES. THE PRODUCT MET MANUFACTURING RELEASE CRITERIA. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ENDED UP PLUS 1.50 HYPEROPIC. THE INTRAOCULAR LENS (IOL) WAS EXCHANGED, FROM THE PATIENT'S LEFT EYE, WITH ANOTHER TECNIS TORIC LENS. THE PATIENT IS DOING WELL AND IS HAPPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708017 TECNIS TORIC IOLS HQL ABBOTT MEDICAL OPTICS ZCT150

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention