BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 20346895 · Received October 1, 2024

    Report

    Report Number
    3012236936-2024-000255
    Event Type
    Injury
    Date Received
    October 1, 2024
    Report Date
    October 1, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2: AGE/DATE OF BIRTH (MONTHS): AGES ARE 68.4 ± 8.8 SECTION A3: SEX/GENDER: (MALE: FEMALE): 7:22 SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED, ARTICLE ACCEPTANCE DATE IS 09 APRIL 2024 . SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE SERIAL LOT/SERIAL NUMBER FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    LITERATURE TITLE: COMPARATIVELY ANALYSING THE POSTOPERATIVE OPTICAL PERFORMANCE OF DIFFERENT INTRAOCULAR LENSES: A PROSPECTIVE OBSERVATIONAL STUDY. A PROSPECTIVE OBSERVATIONAL STUDY WAS DONE TO INVESTIGATE THE POSTOPERATIVE PERFORMANCE OF MONOFOCAL (MON) INTRAOCULAR LENSES (IOLS), SEGMENTAL REFRACTIVE (SEGREF) IOLS, DIFFRACTIVE (DIF) IOLS AND EXTENDED DEPTH OF FOCUS (EDOF) IOLS AND TO EXPLORE THE ASSOCIATION AMONG THE ITRACE OPTICAL METRICS, OPTICAL QUALITY ANALYSIS SYSTEM (OQAS) OPTICAL METRICS, AND BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA). A TOTAL OF 104 EYES OF 104 SUBJECTS UNDERWENT CATARACT SURGERY COMBINED WITH IOL IMPLANTATION AND WERE DIVIDED INTO 4 GROUPS: MON IOLS (N=24 SUBJECTS); SEGREF IOLS (N=25 SUBJECTS); DIF IOLS (N=29 SUBJECTS); AND EDOF IOLS (N=26 SUBJECTS). IN THE EDOF GROUP, THE SUBJECTS WERE IMPLANTED WITH THE TECNIS SYMFONY ZXR00 (JOHNSON & JOHNSON VISION) WHILE IN THE DIF GROUP, THE SUBJECTS WERE IMPLANTED WITH THE TECNIS ZMB00 (JOHNSON & JOHNSON VISION). IN THE EDOF GROUP, IT WAS REPORTED THAT 7 SUBJECTS EXPERIENCED BLUR/DOUBLE VISION(+) AND 1 EYE EXPERIENCED BLUR/DOUBLE VISION(++) WHILE IN THE DIF GROUP, 8 EYES EXPERIENCED BLUR/DOUBLE VISION(+). IN THE EDOF GROUP, IT WAS REPORTED THAT 4 SUBJECTS EXPERIENCED GLARE/HALO(+) WHILE IN THE DIF GROUP, 7 EYES EXPERIENCED GLARE/HALO(+). IN THE EDOF GROUP, IT WAS REPORTED THAT 7 SUBJECTS EXPERIENCED STARBURST(+), 3 SUBJECTS EXPERIENCED STARBURST(++), AND 1 SUBJECTS EXPERIENCED STARBURST(+++) WHILE IN THE DIF GROUP, 11 EYES EXPERIENCED STARBURST(+) AND 8 EYES EXPERIENCED STARBURST(++). IN THE EDOF GROUP, IT WAS REPORTED THAT 11 SUBJECTS EXPERIENCED MIXED FOCUS(+) WHILE IN THE DIF GROUP, 9 EYES EXPERIENCED MIXED FOCUS(+). IN THE EDOF GROUP, IT WAS REPORTED THAT 1 SUBJECT EXPERIENCED NIGHT MYOPIA(+) WHILE IN THE DIF GROUP, 5 EYES EXPERIENCED NIGHT MYOPIA(+). IN THE EDOF GROUP, IT WAS REPORTED THAT 4 SUBJECTS EXPERIENCED NIGHT HYPEROPIA(+) WHILE IN THE DIF GROUP, 3 EYES EXPERIENCED NIGHT HYPEROPIA(+). THERE ARE NO INDICATIONS IN THE ARTICLE OF ANY INTERVENTIONS PROVIDED. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. CITATION: SHUANGLIN GUO, HAO HUANG, BOWEN LI, MANSHA HUANG, LU GAO, JINGYI CHEN, YUYING ZENG, YE YANG, LIN LIU, LU CHENG, SIYANG YAO AND HAO CHENG, COMPARATIVELY ANALYSING THE POSTOPERATIVE OPTICAL PERFORMANCE OF DIFFERENT INTRAOCULAR LENSES: A PROSPECTIVE OBSERVATIONAL STUDY, (2024), BMC OPHTHALMOLOGY; 24 & 198: 1-11 . THIS REPORT IS FOR ZMB00, ANOTHER REPORT WILL BE FILED FOR ZXR00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020065 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Other