BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 20316936 · Received September 26, 2024

    Report

    Report Number
    3012236936-2024-000252
    Event Type
    Injury
    Date Received
    September 26, 2024
    Report Date
    September 26, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2 - AGE: AGE, MEAN±SD, YEARS: 56.5±13.1 [40¿64] SECTION A3B (GENDER): 19 (68%) WOMAN OUT OF 28 PATIENTS. SECTIONS A4, A5: INFORMATION UNKNOWN/NOT PROVIDED. SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED. ARTICLE ACCEPTANCE DATE IS JANUARY 24TH, 2024. THE STUDY WAS CONDUCTED FOR SURGERIES PERFORMED BETWEEN (B)(6) 2020. . SECTION D6B - EXPLANT DATE: N/A, LENS REMAINS IMPLANTED. SECTION H3: THE IMPLANTS WERE NOT RETURNED FOR EVALUATION AS THEY REMAIN IMPLANTED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: CATARINA CASTRO, BRUNO RIBEIRO, INÊS MARIA CAMPOS COUTO, ANA CAROLINA ABREU, SÍLVIA MONTEIRO, MARIA DO CÉU PINTO, LONG-TERM REFRACTIVE OUTCOMES AND VISUAL QUALITY OF MULTIFOCAL INTRAOCULAR LENSES IMPLANTATION IN HIGH MYOPIC PATIENTS: A MULTIMODAL EVALUATION, CLINICAL OPHTHALMOLOGY (2024), DOI: HTTPS://DOI.ORG/10.2147/OPTH.S447827 ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    LONG-TERM REFRACTIVE OUTCOMES AND VISUAL QUALITY OF MULTIFOCAL INTRAOCULAR LENSES IMPLANTATION IN HIGH MYOPIC PATIENTS: A MULTIMODAL EVALUATION A STUDY WAS DONE TO PERFORM A MULTIMODAL ASSESSMENT OF REFRACTIVE OUTCOMES AND QUALITY OF VISION (QOV) IN PATIENTS WITH HIGH MYOPIA SUBMITTED TO MULTIFOCAL INTRAOCULAR LENS (IOL) IMPLANTATION. A TOTAL OF 28 PATIENTS (N=50 EYES) WITH HIGH MYOPIA (AXIAL LENGTH [AL] >26.00MM) WHICH WERE SUBMITTED TO MULTIFOCAL IOL IMPLANTATION WERE INCLUDED. THE IOLS IMPLANTED WERE THE BIFOCAL OR TRIFOCAL ATLISA® (MODELS 809M, 909MP, 909M, 839 MP; 939 MP; CARL ZEISS MEDITEC AG, JENA, GERMANY) AND THE TECNIS® ZLB00 (JOHNSON & JOHNSON VISION, USA). AN ATLISA® IOL WAS IMPLANTED IN 71% AND A TECNIS® IOL IN 29% OF EYES. POSTOPERATIVE COMPLICATIONS INCLUDED: TWO EYES DEVELOPED AN EPIRETINAL MEMBRANE, ONE OF WHICH WITH INTRARETINAL CYSTS AND ONE EYE DEVELOPED PIGMENTED RETINAL EPITHELIUM CHANGES. AT THE LAST FOLLOW-UP VISIT, 46% OF EYES HAD A WORSE UCVA (26% - 1 LOGMAR LINE, 9% - 2 LOGMAR LINES, 4% - 3 LOGMAR LINES, 7% - 4 LOGMAR LINES). OF THE EYES THAT HAD WORSE UCVA AT THE LAST FOLLOW-UP VISIT, 72% HAD A REFRACTIVE ERROR, 14% HAD RETINAL CHANGES, 14% HAD POSTERIOR CAPSULAR OPACIFICATION AND 42% OF EYES HAD ALREADY UNDERGONE ND: YAG POSTERIOR CAPSULOTOMY. AT THE END OF FOLLOW-UP, 3 (11%) PATIENTS REQUIRED EYEGLASSES. TWO REQUIRED EYEGLASSES FOR DISTANCE AND NEAR VISION, AND ONE PATIENT ONLY FOR NEAR ACTIVITIES. IN THE CATQUEST-9SF, 35% OF PATIENTS WERE FAIRLY SATISFIED WITH THEIR CURRENT VISION, AND 13% OF PATIENTS WERE RATHER DISSATISFIED. SOME DEGREE OF DIFFICULTY IN A NEAR-VISION ACTIVITY WAS REPORTED BY 91% OF PATIENTS. READING NEWSPAPER (SOME=52%; GREAT=17%) RECOGNIZING FACES (SOME=26%) READING PRICES (SOME=44%, GREAT=13%, VERY GREAT=13%) WALK ON UNEVEN GROUND (SOME=26%, GREAT=4%) HANDWORK (SOME=61%, GREAT=13%, VERY GREAT=9%) TEXT ON TV (SOME=39%, GREAT=13%) HOBBIES (SOME=22%, GREAT=4%). BCVA (MONTH 1 = 0.09±0.09; LAST FOLLOW-UP = 0.07±0.06) UCVA (MONTH 1 = 0.07±0.08; LAST FOLLOW-UP VISIT = 0.18±0.13) SE (MONTH 1 = 0.07±0.26; LAST FOLLOW-UP = -0.57±0.83) PHOTIC PHENOMENA (LAST FOLLOW-UP = 80%) FREQUENCY OF VISUAL SYMPTOMS: GLARE (OCCASIONALLY = 59%; QUITE OFTEN = 14%) HALOS (OCCASIONALLY = 32%; QUITE OFTEN = 18%) BLURRED (OCCASIONALLY = 55%; QUITE OFTEN = 4%; VERY OFTEN = 9%) DOUBLE VISION (OCCASIONALLY = 18%) FLUCTUATIONS (OCCASIONALLY = 25%; QUITE OFTEN = 5%) HAZY VISION (OCCASIONALLY = 63%; QUITE OFTEN = 5%; VERY OFTEN = 5%) STARBURSTS (OCCASIONALLY = 36%; QUITE OFTEN = 7%) DISTORTION (OCCASIONALLY = 23%) FOCUSING DIFFICULTIES (OCCASIONALLY = 50%; QUITE OFTEN = 4%) JUDGING DISTANCES (OCCASIONALLY = 27%; QUITE OFTEN = 9%). SEVERITY OF VISUAL SYMPTOMS: GLARE (MILD = 69%; MODERATE = 25%) HALOS (MILD = 34%) BLURRED (MILD = 80%; MODERATE = 13%; SEVERE = 7%) DOUBLE VISION (MILD = 75%; MODERATE = 25%) FLUCTUATIONS (MILD = 67%; MODERATE = 33%) HAZY VISION (MILD = 75%; MODERATE = 19%) STARBURSTS (MILD = 73%; MODERATE = 18%) DISTORTION (MILD = 60%; MODERATE = 40%) FOCUSING DIFFICULTIES (MILD = 67%; MODERATE = 17%; SEVERE = 8%) JUDGING DISTANCES (MILD = 50%; MODERATE = 25%; SEVERE = 25%). BOTHERSOME: GLARE (MILD = 69%; MODERATE = 6%) HALOS (MILD = 64%; MODERATE = 18%) BLURRED (MILD = 73%; MODERATE = 13%) DOUBLE VISION (MILD = 75%) FLUCTUATIONS (MILD = 50%; MODERATE = 33%) HAZY VISION (MILD = 68%; MODERATE = 19%) STARBURSTS (MILD = 55%; MODERATE = 9%) DISTORTION (MILD = 60%; MODERATE = 20%) FOCUSING DIFFICULTIES (MILD = 58%; MODERATE = 8%) JUDGING DISTANCES (MILD = 56%; MODERATE = 22%; SEVERE = 11%) . IT WAS UNSURE WHETHER THE EVENTS OCCURRED TO THOSE IMPLANTED WITH THE J&J DEVICE OR THE NON-J&J DEVICE USED IN THE STUDY. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1610684 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS ZLB00

    Patients

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