BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS DELTA

    MDR report key: 21939748 · Received April 30, 2025

    Report

    Report Number
    3012236936-2025-000118
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Report Date
    April 30, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A RETROSPECTIVE, SINGLE-CENTER STUDY INVESTIGATED REAL-WORLD OUTCOMES OF CATARACT SURGERIES USING THE TECNIS EYHANCE TORIC II INTRAOCULAR LENS (IOL) IN A TOTAL OF 41 PATIENTS (N=62 EYES) WITH REGULAR ASTIGMATISM. THE IOLS USED INCLUDED DIU 100 (N=3), DIU 150 (N=29), DIU 225 (N=15), DIU 300 (N=10), AND DIU 375 (N=5). THE STUDY EMPLOYED THE ONLINE TECNIS® TORIC CALCULATOR (JOHNSON & JOHNSON SURGICAL VISION®), ABERROMETER ITRACE®, AND CATALYS¿ PRECISION LASER SYSTEM FEMTOSECOND LASER. MISALIGNMENT FROM THE INTENDED IMPLANTATION AXIS WAS NOT ASSESSED IN 18 EYES DURING THE POSTOPERATIVE PERIOD. CONSEQUENTLY, IOL MISALIGNMENT WAS ANALYZED IN 44 EYES AT THREE MONTHS POSTOPERATIVELY. THE AVERAGE ABSOLUTE MISALIGNMENT WAS 3.41 ± 2.44° (RANGE, 0°¿10°), AND NONE OF THE EYES REQUIRED REPOSITIONING OF THE IOL. ONE CASE WITH SUBOPTIMAL POSTOPERATIVE ASTIGMATISM RESULTS WAS IDENTIFIED. A PATIENT WITH AN AXIAL LENGTH OF 26.74 MM AND A PREOPERATIVE CORNEAL CYLINDER OF 1.25 D AT 26 DEGREES IN THE RIGHT EYE UNDERWENT CATARACT SURGERY WITH THE DIU 150 TORIC IOL. ON POSTOPERATIVE DAY 1, THE VISUAL AND REFRACTIVE OUTCOMES WERE EXCELLENT, AND THE ANGLE OF ERROR WAS MINIMAL AT 0.38 DEGREES. HOWEVER, BY POSTOPERATIVE MONTH 3, THE PATIENT PRESENTED WITH A LOGMAR UNCORRECTED DISTANCE VISUAL ACUITY (UDVA) OF 0.30 AND A REFRACTIVE CYLINDER OF 1.00 D. EXAMINATION UNDER FULL PUPIL DILATION REVEALED A MISALIGNMENT OF 9 DEGREES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024176 TECNIS DELTA LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other