BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 8920148 · Received August 22, 2019

    Report

    Report Number
    9614546-2019-00764
    Event Type
    Injury
    Date Received
    August 22, 2019
    Report Date
    November 10, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE (B)(4), AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    AGES/DATE(S) OF BIRTH: UNKNOWN. GENDER(S)SEX(ES): UNKNOWN. DATE(S) OF EVENT: UNKNOWN. SERIAL NUMBER(S): UNKNOWN. CATALOG #(''S): COMPLETE CATALOG #''S ARE UNKNOWN. UDI #(''S): UNKNOWN. EXPIRATION DATE(S): UNKNOWN. IF IMPLANTED; GIVE DATE(S): UNKNOWN. IF EXPLANTED; GIVE DATE(S): UNKNOWN. INITIAL REPORTER PHONE NUMBER: UNKNOWN. THE DEVICES WERE NOT RETURNED FOR ANALYSIS. THE SERIAL NUMBERS FOR THE DEVICES WERE NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE(S): UNKNOWN. (B)(4). CITATION: HIROKO BISSEN-MIYAJIMA, YUKA OTA, KUNIHIKO NAKAMURA, MANABU HIRASAWA, AND KEIICHIRO MINAMI (2019). BINOCULAR VISUAL FUNCTION WITH STAGED IMPLANTATION OF DIFFRACTIVE MULTIFOCAL INTRAOCULAR LENSES WITH THREE ADD POWERS. AM J OPHTHALMOL. 2019 MAR,199, PP223-229. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ARTICLE: BINOCULAR VISUAL FUNCTION WITH STAGED IMPLANTATION OF DIFFRACTIVE MULTIFOCAL INTRAOCULAR LENSES WITH THREE ADD POWERS. AUTHORS: HIROKO BISSEN-MIYAJIMA, YUKA OTA, KUNIHIKO NAKAMURA, MANABU HIRASAWA, AND KEIICHIRO MINAMI. PUBLICATION: AM J OPHTHALMOL. 2019 MAR;199:223-229. PURPOSE: TO EVALUATE THE BINOCULAR VISUAL FUNCTION AND DEPTH OF FOCUS AFTER STAGED IMPLANTATION OF DIFFRACTIVE MULTIFOCAL INTRAOCULAR LENSES (MIOLS) WITH 3 DIFFERENT ADD POWERS FOLLOWING CATARACT REMOVAL. DESIGN: PROSPECTIVE COMPARATIVE CASE SERIES. METHODS: SETTING: INSTITUTIONAL. STUDY POPULATION. BOTH EYES OF 56 PATIENTS THAT UNDERWENT STAGED IMPLANTATION OF BIFOCAL IOLS. INTERVENTION: IN THE FIRST EYE, MIOLS WITH A D4.0-DIOPTER (D) ADD POWER WERE IMPLANTED. BASED ON OUTCOMES AT 1 WEEK POSTOPERATIVELY AND PATIENT PREFERENCE FOR NEAR VISION, 1 OF 3 NEAR ADD POWERS¿D4.0 D (GROUP MM), D3.25 D (GROUP ML), OR D2.75 D (GROUP MK) WAS IMPLANTED IN THE FELLOW EYE. MAIN OUTCOME MEASURE(S): THREE MONTHS POSTOPERATIVELY, THE BINOCULAR UNCORRECTED AND DISTANCE CORRECTED VISUAL ACUITIES (BUCVA AND BDCVA, RESPECTIVELY) AT 5.0, 1.0, 0.5, 0.4, AND 0.3 METERS; BINOCULAR DEFOCUS CURVES; CONTRAST SENSITIVITY; AND NEAR STEREOPSIS WERE MEASURED. THE PUBLICATION REPORTS, OF 21 PATIENTS IMPLANTED WITH THE ZMB00 +4.00 IOL, 38% DEVELOPED GLARE, 38% HALOS, AND 38% LOW CONTRAST SENSITIVITY. OF 18 PATIENTS IMPLANTED WITH EITHER ZLB00 OR ZMB00 +3.25, 33% DEVELOPED GLARE, 44% DEVELOPED HALOS AND 44% LOW CONTRAST SENSITIVITY. OF 17 PATIENTS IMPLANTED WITH EITHER ZMB00 OR ZKB00 + 2.75, 41% DEVELOPED GLARE, 24% DEVELOPED HALOS, AND 53% DEVELOPED LOW CONTRAST SENSITIVITY. ONE PATIENT IMPLANTED WITH ZMB00 + 4.00 NEEDED TO WEAR SPECTACLE CORRECTION FOR DISTANCE VISION AND UNDERWENT LASIK SURGERY 6 MONTHS LATER TO CORRECT THIS. RESULTS: THE MM, ML, AND MK GROUPS INCLUDED 21, 18, AND 17 PATIENTS, RESPECTIVELY. THE MEAN BUCVA IN THE MM GROUP WAS SIGNIFICANTLY (P[.003) WORSE THAN THAT IN THE MK GROUP AT 0.5 METER. THE BDCVAS AT 0.5 METER IN THE ML AND MK GROUPS WERE SIGNIFICANTLY (P<.02) BETTER THAN THAT IN THE MM GROUP. THE DEFOCUS CURVES WITH THE -2.0 D REFRACTION DIFFERED SIGNIFICANTLY (P<.001) BETWEEN THE MM AND MK GROUPS. THE BINOCULAR CONTRAST SENSITIVITY AND STEREOPSIS VALUES DID NOT DIFFER SIGNIFICANTLY. CONCLUSIONS: STAGED IMPLANTATION OF DIFFERENT ADD POWERS OBTAINED BETTER BINOCULAR INTERMEDIATE VISUAL ACUITY WITHOUT DEGRADATION OF VISUAL FUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. THIS REPORT IS FOR THE MODEL NO. ZMBOO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713292 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention