BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 8562407 · Received April 29, 2019

    Report

    Report Number
    9614546-2019-00378
    Event Type
    Injury
    Date Received
    April 29, 2019
    Date of Event
    October 9, 2017
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474605138
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 (B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS REMAINS IMPLANTED. (B)(4). THE DEVICE IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE/LOT HISTORY RECORD, LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED A ZXT150, 16.5 DIOPTER INTRAOCULAR LENS (IOL) ON (B)(6) 2017. FOLLOW-UP CONFIRMED THAT VISUAL ISSUES STARTED RIGHT AFTER SURGERY. INITIALLY, THE SYMPTOM WAS DESCRIBED AS SHE FEELS LIKE SHE HAS A FILM IN HER RIGHT EYE, BUT FOLLOW-UP CLARIFIED AS SYMPTOM TO BE "FOG/BLURRED" COVERING HER EYE. HER NIGHT DRIVING IS HORRIBLE WITH BLURRY SENSATION LIKE SHE ALWAYS HAS TO CLEAN HER LENSES AS SHE CANNOT SEE CLEARLY. BUT HER DOCTOR SAID THAT HER VISION IS 20/20 NEVERTHELESS, HER VISUAL CONCERNS ANNOY HER. SHE CLAIMS THAT THE VISUAL ISSUES SIGNIFICANTLY INTERFERE WITH HER REGULAR ACTIVITIES. SHE SAID THAT SHE DOES VOLUNTEER WORK BUT HAVE NOT DONE IT ANYMORE BECAUSE OF HER VISUAL CONCERNS. SHE KEPT ON GOING TO HER DOCTOR TO LET THEM KNOW OF HER ISSUES. SHE HAD LASIK IN BOTH EYES TO TRY TO FIX RIGHT EYE AS SHE CLAIMED THAT THE DOCTOR TOLD HER HE MIGHT AS WELL DO BOTH EYES. BUT IT SEEMS THAT THE DOCTOR HAS ALREADY GIVEN UP ON HER. WHEN ASKED ABOUT THE BIONIC FILM GRAFT THAT SHE MENTIONED IN THE INITIAL REPORT, SHE STATED THAT IT WAS DONE ON (B)(6) 2019, AND WAS ABOUT A PIECE SKIN GRAFT THAT WAS PUT IN HER EYE WHICH THE DOCTOR SAID MAY HELP WITH HER VISUAL ISSUES OF BLURRY/FOGGINESS BUT THE GRAFT DID NOT WORK. NEVERTHELESS, THE PATIENT STILL SEE FLOATERS, STILL BLUR/FOGGY VISION, IN FACT THEY ARE WORSE NOW. SHE WENT BACK TO HER DOCTOR WHO REMOVED THE GRAFT AND TOLD HER THAT HER BODY REJECTED IT. HENCE, IT DID NOT WORK. THE DOCTOR THEN TOLD HER HE WILL SEE HER IN 3 MONTHS FOR HER GLAUCOMA APPOINTMENT. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353739 TECNIS SYMFONY TORIC MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXT150 05050474605138

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention