BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 21971607 · Received May 6, 2025

    Report

    Report Number
    3012236936-2025-000128
    Event Type
    Injury
    Date Received
    May 6, 2025
    Report Date
    May 6, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B3: DATE OF EVENT: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: ADDITIONAL DEVICE INFORMATION: CATALOG NUMBER: UNKNOWN SECTION D4: ADDITIONAL DEVICE INFORMATION: SERIAL NUMBER: UNKNOWN SECTION D4: ADDITIONAL DEVICE INFORMATION: EXPIRATION DATE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS EXPLANTED SECTION E1: REPORTER: MIDDLE NAME: UNKNOWN, INFORMATION NOT PROVIDED. SECTION E1: REPORTER: ADDRESS - LINE 2: UNKNOWN, INFORMATION NOT PROVIDED. SECTION E1: REPORTER: TELEPHONE NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE SERIAL NUMBER FOR THIS DEVICE IS UNKNOWN/NOT PROVIDED; THEREFORE, NO FURTHER PRODUCT INVESTIGATION CAN BE PERFORMED. SHOULD ANY FURTHER RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED. CITATION: WANG, J., LUO, J., YANG, W., REN, R., XIE, Y., LI, J., GUAN, H., & JI, M. (2024). EFFICACY AND COMFORT FOLLOWING THE IMPLANTATION OF EXTENDED DEPTH OF FOCUS, MULTIFOCAL, AND MONOFOCAL INTRAOCULAR LENSES IN CATARACT PATIENTS. BMC OPHTHALMOLOGY, 24(1), 423. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A LITERATURE ARTICLE TITLED "EFFICACY AND COMFORT FOLLOWING THE IMPLANTATION OF EXTENDED DEPTH OF FOCUS, MULTIFOCAL, AND MONOFOCAL INTRAOCULAR LENSES (IOLS) IN CATARACT PATIENTS" THAT A PROSPECTIVE STUDY WAS DONE TO COMPARE THE VISION, COMFORTABLE NEAR DISTANCE (CND) AND VISUAL COMFORT IN PATIENTS WHO UNDERWENT IMPLANTATION OF EDOF, MULTI, AND MONOFOCAL (MONO) IOLS. A TOTAL OF 100 EYES UNDERWENT CATARACT SURGERY AND WERE IMPLANTED WITH EITHER THE TECNIS® SYMFONY, ZXR00V (N=33 EYES; EDOF GROUP) (JOHNSON & JOHNSON SURGICAL VISION INC.), THE TECNIS® ZMB00 IOL(MIOL) (N=34; EYES; MULTIFOCAL GROUP) (JOHNSON & JOHNSON SURGICAL VISION INC.), OR THE TECNIS® ZCB00 IOL (N=33 EYES; MONOFOCAL GROUP) (JOHNSON & JOHNSON VISION INC.). AT 3 MONTHS POST-OP, COMPARISON OF LETTER CLARITY BETWEEN CND AND STANDARD NEAR DISTANCE WERE ASSESSED IN WHICH BLURRIER AND HARDER VISUAL EXPERIENCE WERE REPORTED BY 4 PATIENTS IN THE EDOF GROUP, 1 PATIENT IN THE MULTIFOCAL GROUP, AND 6 PATIENTS IN THE MONOFOCAL GROUP WHILE UNCHANGED VISUAL EXPERIENCE WERE REPORTED BY 13 PATIENTS IN THE EDOF GROUP, 14 PATIENTS IN THE MULTIFOCAL GROUP, AND 10 PATIENTS IN THE MONOFOCAL GROUP. THE LEVEL OF RECIPIENT¿S VISUAL HEALTH AND COMFORT (VICO) AT CND WERE ASSESSED IN WHICH MILD VISUAL FATIGUE WAS REPORTED BY 19% OF PATIENTS IN THE EDOF GROUP, 9% OF PATIENTS IN THE MULTIFOCAL GROUP, AND 30% OF PATIENTS IN THE MONOFOCAL GROUP. OBVIOUS VISUAL FATIGUE BUT TOLERABLE WAS REPORTED BY 3% OF PATIENTS IN THE EDOF GROUP, 5% OF PATIENTS IN THE MULTIFOCAL GROUP, AND 25% OF PATIENTS IN THE MONOFOCAL GROUP. ONLY ONE RECIPIENT IN THE MULTI GROUP RATED THIS EXPERIENCE AS SEVERELY FATIGUE-INDUCING WITH VARIOUS DISCOMFORT SYMPTOMS AND WAS UNABLE TO TOLERATE IT. THE LEVEL OF RECIPIENT¿S VICO AT STANDARD NEAR DISTANCE WERE ALSO ASSESSED IN WHICH MILD VISUAL FATIGUE WAS REPORTED BY 40% OF PATIENTS IN THE EDOF GROUP, 39% OF PATIENTS IN THE MULTIFOCAL GROUP, AND 41% OF PATIENTS IN THE MONOFOCAL GROUP. OBVIOUS VISUAL FATIGUE BUT TOLERABLE WAS REPORTED BY 10% OF PATIENTS IN THE EDOF GROUP, 12% OF PATIENTS IN THE MULTIFOCAL GROUP, AND 36% OF PATIENTS IN THE MONOFOCAL GROUP. INTENSE VISUAL FATIGUE THAT REQUIRES IMMEDIATE CESSATION (TREATMENT) WAS REPORTED BY 1% OF PATIENTS IN THE MULTIFOCAL GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99485 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other