BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 7243147 · Received February 5, 2018

    Report

    Report Number
    9614546-2018-00115
    Event Type
    Injury
    Date Received
    February 5, 2018
    Report Date
    August 8, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    POE
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE IS (B)(6) 2017. THE SERIAL NUMBER WAS NOT PROVIDED. THE LENS REMAINS IMPLANTED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORD CANNOT BE REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ZXT300 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. THE PATIENT IS A FEW WEEKS OUT (POST OP). REPORTEDLY, THE DOCTOR INDICATED THAT AN IOL EXCHANGE MAY NEED TO BE DONE BECAUSE THE PATIENT HAD A 2 DIOPTER OF RESIDUAL CYLINDER POST-OPERATIVELY. ON (B)(6) 2018, THE PATIENT SAW THE DOCTOR FOR ADDITIONAL MEASUREMENTS, WHICH HAD THE FOLLOWING RESULTS: K1 41.96, K2 45.12 AT 113 WITH 3.12 CYLINDER, AND USING A 119.3 CONSTANT, A 19.5 = -0.11. FURTHERMORE, DISTANCE VISION WAS 20/50 AND J5. REPORTEDLY, THE DOCTOR THINKS THE CORRECT REFRACTION WOULD BE -0.75 X 2.0 X 105 AND WITH THAT DISTANCE IS 20/20. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84672 TECNIS SYMFONY TORIC MULTIFOCAL IOLS POE ABBOTT MEDICAL OPTICS ZXT300

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention