BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 9189135 · Received October 14, 2019

    Report

    Report Number
    9614546-2019-00968
    Event Type
    Injury
    Date Received
    October 14, 2019
    Date of Event
    September 10, 2019
    Report Date
    November 9, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474552616
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-(B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: PRODUCT EVALUATION WAS NOT PERFORMED AS THE LENS WAS NOT RETURNED; IT REMAINS. THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH OF COMPLAINTS REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER. BASED ON THE RESULTS OF THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR IMPLANTED, IN PATIENT'S LEFT EYE, A MODEL ZCT525 INTRAOCULAR LENS BASED ON THE RESULTS TAKEN FROM THE LENS CALCULATIONS DONE (B)(6) 2019. THE PATIENT HAD A 3D (DIOPTER) ASTIGMATISM CORRECTION REQUIREMENT. LENS WAS PLACED. REPORTEDLY, THE PATIENT HAD SOME CORNEAL EDEMA AND WAS 20/400 POST OP. DOCTOR INDICATED A LENS EXCHANGE MAY BE NECESSARY; HOWEVER, PATIENT DOES NOT WANT ANOTHER SURGERY DUE TO HER OTHER HEALTH CONDITIONS, REPORTED TO BE A RECENT STROKE. FURTHER INFORMATION WAS PROVIDED AND INDICATES THE DOCTOR USED THE RECOMMENDATION FROM THE TORIC CALCULATOR COMPLETED (B)(6) 2019. IT SUGGESTS A ZCT525 FOR CORRECTION OF 3 D OF CYLINDER SO THE ZCT525 WAS IMPLANTED. TO ASSIST THE DOCTOR, THE ACCOUNT EXECUTIVE RERAN THE NUMBERS THROUGH THE CALCULATOR AND IT RECOMMENDED A MODEL ZCT400. PATIENT WILL CONTINUE TO BE SEEN IN FOLLOW UP VISITS. PER THE DOCTOR, ON LINE J OF THE CALCULATOR IT RECOMMENDED A MODEL ZCT525 FOR IMPLANT IN THE PATIENT'S EYE; HOWEVER, AT POST OP, PATIENT WAS OVER CORRECTED FOR ASTIGMATISM. POST OP VISIT: (B)(6) 2019 - PATIENT VISUAL ACUITY 20/70 AND NO NEAR VISION. FURTHER UPDATE FROM THE DOCTOR RECEIVED (B)(6) 2019, REPORTS THE PATIENT HAD HER COMPANION (RIGHT) EYE IMPLANTED WITH A MODEL ZCT225 (B)(6) 2019. PATIENT HAS ANISOMETROPIA BECAUSE OF ERROR OF SOFTWARE FOR LENS CALCULATION FOR THE LEFT EYE. PATIENT DOES NOT WANT ANY FURTHER SURGERY BECAUSE OF HEALTH REASONS. RECENT VISIT NOTES PATIENT SEES 20/50, ZERO CLOSE UP, + 1.50 CYLINDER IN THE OPPOSITE DIRECTION BUT NOT CLEAR VISION. PATIENT IS HAPPY TO WEAR GLASSES. THE GLASSES CORRECT THE UNEXPECTED POST OP RESULTS. THIS REPORT REPRESENTS THE RIGHT EYE. A SEPARATE REPORT IS BEING FILED FOR THE LEFT EYE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977900 TECNIS TORIC IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCT225 05050474552616

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other