BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 10451346 · Received August 25, 2020

    Report

    Report Number
    9614546-2020-00335
    Event Type
    Injury
    Date Received
    August 25, 2020
    Date of Event
    January 14, 2020
    Report Date
    October 29, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474604988
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H-6 PATIENT CODE: 1937 WAS REPORTED IN THE INITIAL REPORT. HOWEVER, UPON FURTHER REVIEW THE IOP CODING IS NOT APPLICABLE BECAUSE IT IS PART OF THE NORMAL PRACTICE TO TREAT AFTER AN IOL IMPLANT. THERE IS NO INDICATION THAT THE IOP IS HIGHER THEN EXPECTED POST-OPERATIVELY. SECTION H-6 PATIENT CODE: 2140 WAS ADDED AS THE INFORMATION WAS KNOWN AT THE TIME OF THE INITIAL REPORT, BUT INADVERTENTLY NOT INCLUDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    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-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE INTRAOCULAR LENS REMAINS IMPLANTED IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE). FACILITY NAME: NOT APPLICABLE, AS THE PATIENT REPORTED THE EVENT. IT WAS INDICATED THAT THE IOL IS NOT BEING RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE). THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE/LOT HISTORY RECORD AND HISTORICAL DATA ANALYSIS FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) (B)(6) 2020. PATIENT REPORTS THAT SHE NEVER HAD CLEAR VISION AFTER HER SURGERY, AND STATED HER VISION IS BLURRED UP TO 27 INCHES IN FRONT OF HER. SHE WAS ASSURED SHE WOULD HAVE MID-RANGE VISION AND SHE DOES NOT. SHE HAS NOT BEEN ABLE TO READ LABELS, SEE HER PHONE, LEMON SEEDS, ETC. SINCE DAY OF SURGERY. DISTANCE VISION IS PRETTY GOOD, BUT SHE STILL CAN¿T SEE SIGNS AT NIGHT WHEN SHE IS DRIVING OR ANYTHING CLOSE-UP. STREET SIGNS ARE VISIBLE IF SHE SITS AND FOCUSES ON THEM AT STOP SIGNS, BUT NOT IN THE APPROACHING DISTANCE OR WHIRRING BY. SHE HAS TRIED 3 PAIRS OF GLASSES IN ORDER TO SEE WITH THE FOLLOWING RESULTS: POWER OF 3.25 ALLOWS HER TO SEE AT PRECISELY 10 INCHES. BUT NOT CLOSER OR FARTHER. POWER OF 2.0 ALLOWS HER TO SEE ~2 FEET WITH NO MIDRANGE. SIGNS WITH SMALLER PRINT THAN SPEED LIMITS ARE BLURRY. CANNOT SEE THE SIGNS, LET ALONE WORDS ON THEM AT NIGHT. POWER 1.5 ALLOWS HER TO DRIVE, BUT SHE CAN¿T READ HER PHONE WITH IT. SHE HAS TRIED DIFFERENT CONTACTS AND THIS DID NOT WORK EITHER; CANNOT SEE LABELS WITH +.25 ADD HIGH CONTACT LENS. SHE HAS USED EYE DROPS BUT IT HASN¿T HELPED. PRE & POST-OPERATIVE DROPS ARE BESIVANCE, DUREZOL/LOTEMAX, PROLENZA, PRESERVATIVE FREE TEARS & XIIDRA TO IMPROVE TEAR FILM. ALSO SIMBRINZA DROPS WERE USED DURING LAST 10 DAYS OF HEALING FOR REDUCING EYE PRESSURE. SHE SAW HER DR. LAST A FEW WEEKS AGO. SHE DOESN¿T HAVE A SATISFACTORY OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913862 TECNIS SYMFONY TORIC MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXT150 05050474604988

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other BAUSCH+LOMB CAPSULAR TENSION RING