BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 7708257 · Received July 20, 2018

    Report

    Report Number
    9614546-2018-00698
    Event Type
    Injury
    Date Received
    July 20, 2018
    Date of Event
    August 16, 2017
    Report Date
    October 30, 2020
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474605756
    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 NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    EXPLANT DATE: IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS REMAINS IMPLANTED. (B)(4). REASON FOR NON-EVALUATION: IT WAS INDICATED THAT THE DEVICE REMAINS IMPLANTED AND IS NOT RETURNING FOR EVALUATION; 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 AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH TWO TECNIS SYMFONY INTRAOCULAR LENSES (IOL) AND EXPERIENCED PROFOUND STARBURSTS AND HALOS ALMOST IMMEDIATELY AFTER SURGERY. THE PATIENT INDICATED THAT HE CONTINUES TO HAVE SEVERE PROBLEMS WITH NIGHT DRIVING AND THAT HE SEES CONCENTRIC CIRCLES AROUND TRAFFIC LIGHTS RADIATING OUTWARD ABOUT FOUR OR FIVE TIMES THE DIAMETER OF THE LIGHT. HE INDICATED THAT HE SEES LARGE HALOS AROUND STREET LIGHTS, TRAFFIC LIGHTS, THE MOON, IN THE THEATER AND ANY LIGHT IN THE DARK. THE PATIENT ALSO MENTIONED THAT HE SEES VERY DISTRACTING AND LARGE STARBURSTS FROM ONCOMING HEADLIGHTS, SO LARGE THAT THEY SOMETIMES BLOCK OUT MOST OF HIS LANE. THE PATIENT REPORTED THAT HE WAS INVOLVED IN A TRAFFIC ACCIDENT WHERE HE HIT ANOTHER CAR. THE SURGEON PERFORMED A YAG LASER CAPSULOTOMY ON THE LEFT EYE SHORTLY AFTER SURGERY, AS THE PATIENT HAD DEVELOPED A SECONDARY CATARACT/ PCO (POSTERIOR CAPSULE OPACIFICATION). HOWEVER, THE CUSTOMER MENTIONED THAT THE YAG LASER CAPSULOTOMY DID NOT CHANGE ANYTHING. THE PATIENT HAS TRIED YELLOW ANTI-GLARE NIGHT DRIVING GLASSES, BUT THEY HAVE BEEN NOT HELPFUL. THE DOCTOR SUGGESTED A YAG ON THE RIGHT EYE ALTHOUGH HE DID NOT SEE ANY PCO. THE PATIENT IS SKEPTICAL ABOUT HAVING THE YAG PERFORMED ON THE RIGHT EYE. A PROCEDURE FOR THE RIGHT EYE HAS NOT BEEN SCHEDULED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC. NOTE: 2 MDR¿S WILL BE SUBMITTED, ONE FOR EACH AFFECTED EYE. THIS MDR CAPTURES THE INFORMATION PERTAINING TO THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550185 TECNIS SYMFONY TORIC MULTIFOCAL IOLS POE JOHNSON AND JOHNSON SURGICAL VISION, INC. ZXT225 05050474605756

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention