BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 20364670 · Received October 3, 2024

    Report

    Report Number
    3012236936-2024-000268
    Event Type
    Injury
    Date Received
    October 3, 2024
    Report Date
    October 3, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    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 51.9 ± 5.8 SECTION A3: SEX/GENDER: (MALE: FEMALE): 6:7 . SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED, ARTICLE ACCEPTANCE DATE IS 2 APRIL 2024 . SECTION H3-: 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. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: SHUANG NI, BAOXIAN ZHUO, LEI CAI, MIN WANG, JIYING SHEN, LIMEI ZHANG, WENQIAN SHEN, HAIKE GUO & JIN YANG, VISUAL OUTCOMES AND PATIENT SATISFACTION AFTER IMPLANTATIONS OF THREE TYPES OF PRESBYOPIA-CORRECTING INTRAOCULAR LENSES THAT HAVE UNDERGONE CORNEAL REFRACTIVE SURGERY, (2024), SCIENTIFIC REPORTS; 14& 8386: PP 1-9. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    LITERATURE TITLE: VISUAL OUTCOMES AND PATIENT SATISFACTION AFTER IMPLANTATIONS OF THREE TYPES OF PRESBYOPIA-CORRECTING INTRAOCULAR LENSES THAT HAVE UNDERGONE CORNEAL REFRACTIVE SURGERY. A PROSPECTIVE, NON-RANDOMIZED, COMPARATIVE STUDY WAS DONE TO COMPARE THE VISUAL OUTCOMES AND PATIENT SATISFACTION AFTER IMPLANTATIONS OF THREE PRESBYOPIA-CORRECTING INTRAOCULAR LENSES (IOLS) AFTER MYOPIC REFRACTIVE SURGERY. THERE WERE 45 PATIENTS (N=90 EYES) INITIALLY INCLUDED AND DIVIDED INTO THREE GROUPS BASED ON THE THREE TYPES OF PRESBYOPIA-CORRECTING IOLS IMPLANTED (839MP, MF30, AND ZXR00), WHICH WERE DECIDED BY THE PATIENTS THEMSELVES. THOSE WITH CHANGED SURGICAL APPROACH DUE TO INTRAOPERATIVE COMPLICATIONS (N=3 EYES; N=1 IN THE 839MP GROUP AND N=2 IN THE MF30 GROUP) AND THOSE LOST TO FOLLOW-UP (N=8 EYES: N=3 IN THE 839MP GROUP, N=2 IN THE MF30 GROUP, AND N=4 IN THE ZXR00 GROUP) WERE EXCLUDED. PATIENTS WITH ONLY 1 EYE AVAILABLE WERE EXCLUDED TO AVOID POTENTIAL BIAS. FINALLY, A TOTAL OF 39 PATIENTS (N=78 EYES) WHO WERE BINOCULARLY IMPLANTED AS REQUIRED WERE ANALYZED: 839MP (N=26 EYES) FOR FULL VISUAL ACUITY (VA); TECNIS SYMPHONY ZXR00 (N=26 EYES) FOR INTERMEDIATE-TO-DISTANCE VA; AND MF30 (N=26 EYES) FOR NEAR-TO-DISTANCE VA. AT 3 MONTHS POSTOPERATIVELY: FOR ZXR00 (3.0MM PUPIL): TOTAL HOA COMA (¿) = 0.06±0.04; TOTAL HOA SPH (¿) = 0.04±0.02; TOTAL HOA TREFOIL (¿) = 0.05±0.05 FOR ZXR00 (4.0MM PUPIL): TOTAL HOA COMA (¿) = 0.42±0.19; TOTAL HOA SPH (¿) = 0.39±0.10; TOTAL HOA TREFOIL (¿) = 0.43±0.15 ZXR00 GROUP SCORED SIGNIFICANTLY LOWER FOR ¿READING SMALL PRINT,¿ ¿READING A NEWSPAPER,¿ AND ¿DOING FINE HANDWORK¿ (P1=0.015, P2=0.000, P3=0.000) BASED ON PAIRWISE COMPARISON COMPARED WITH OTHER 2 GROUPS. ZXR00 SPECTACLE INDEPENDENCE FOR DISTANCE VISION RATE: 25% HALO (ZXR00): 39%. RESIDUAL ASTIGMATISM DID NOT DIFFER SIGNIFICANTLY ACROSS THE THREE GROUPS (P=0.359). THERE WERE NO FURTHER INTERVENTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553263 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS ZXR00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose