BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 8933591 · Received August 26, 2019

    Report

    Report Number
    9614546-2019-00778
    Event Type
    Injury
    Date Received
    August 26, 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 Location
    HK
    Reporter Occupation
    PHYSICIAN

    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 NR-(B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    AGES/DATE(S) OF BIRTH: THE EXACT DATE OF BIRTH OF THE PATIENTS ARE UNKNOWN. HOWEVER, THE PATIENTS AGE RANGED FROM 44 TO 72 GENDER(S)SEX(ES): 32(89%) OF THE PATIENTS WERE WOMEN. DATE(S) OF EVENT: THE EXACT DATE OF EVENT IS UNKNOWN. THE BEST ESTIMATE IS BETWEEN AUGUST 2012 AND APRIL 2014. SERIAL NUMBER(S): UNKNOWN, NOT PROVIDED. CATALOG #(''S): COMPLETE CATALOG #''S ARE UNKNOWN AS SERIAL NUMBERS WERE NOT PROVIDED. UDI #(''S): UNKNOWN, AS SERIAL NUMBERS WERE NOT PROVIDED. EXPIRATION DATE(S): UNKNOWN AS THE SERIAL NUMBERS WERE NOT PROVIDED. IF IMPLANTED; IF EXPLANTED; GIVE DATE(S): UNKNOWN, NOT PROVIDED. INITIAL REPORTER PHONE NUMBER: UNKNOWN, NOT PROVIDED 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, AS SERIAL NUMBERS WERE NOT PROVIDED. (B)(4). CITATION: JOHN S.M. CHANG, MD (2019). BILATERAL IMPLANTATION OF A SINGLE-PIECE BIFOCAL DIFFRACTIVE INTRAOCULAR LENS IN PRESBYOPIC PATIENTS: A PROSPECTIVE CASE SERIES. ASIA PAC J OPHTHALMOL (PHILA) 2019;8(1):PP12¿21. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ARTICLE: BILATERAL IMPLANTATION OF A SINGLE-PIECE BIFOCAL DIFFRACTIVE INTRAOCULAR LENS IN PRESBYOPIC PATIENTS: A PROSPECTIVE CASE SERIES. AUTHOR: JOHN S.M. CHANG, MD. PUBLICATION: ASIA PACIFIC ACADEMY OF OPHTHALMOLOGY 2019;8(1).PP12¿21. PURPOSE: TO REPORT VISUAL OUTCOMES AND QUALITY AFTER BILATERAL IMPLANTATION OF A SINGLE-PIECE DIFFRACTIVE MULTIFOCAL INTRAOCULAR LENS (MIOL) WITH A BIFOCAL DESIGN. DESIGN: PROSPECTIVE, OBSERVATIONAL CASE SERIES. METHODS: ALL PRESBYOPIC SUBJECTS WERE IMPLANTED WITH THE ZMB00 MIOL (ABBOTT MEDICAL OPTICS) AT THE HONG KONG SANATORIUM AND HOSPITAL. WE EVALUATED THE DISTANCE, INTERMEDIATE, AND NEAR VISUAL ACUITY (VA) UNDER PHOTOPIC AND MESOPIC CONDITIONS; CONTRAST SENSITIVITY WITH AND WITHOUT GLARE UNDER PHOTOPIC AND MESOPIC CONDITIONS; QUALITY OF VISION; AND RATE OF SPECTACLE INDEPENDENCE. RESULTS: A TOTAL OF 36 SUBJECTS WERE INCLUDED. NO INTRAOPERATIVE COMPLICATIONS DEVELOPED. AT THE 6-MONTH VISIT, THE MEAN (± STANDARD DEVIATION) MONOCULAR UNCORRECTED VAS AT DISTANCE, INTERMEDIATE, AND NEAR WERE 0.01 ± 0.12, 0.26 ± 0.17, AND 0.09 ± 0.08, RESPECTIVELY. THE RESPECTIVE MEAN BINOCULAR UNCORRECTED VAS WERE -0.05 ± 0.09, 0.12 ± 0.13, AND 0.04 ± 0.06. NO EYES LOST ANY CORRECTED DISTANCE VA. THE BINOCULAR CONTRAST SENSITIVITY WAS SIGNIFICANTLY BETTER WITHOUT GLARE THAN WITH GLARE UNDER PHOTOPIC AND MESOPIC CONDITIONS (P< 0.05 FOR ALL SPATIAL FREQUENCIES UNDER BOTH CONDITIONS). A TOTAL OF 21 (58%) AND 21 SUBJECTS (58%) REPORTED HALO AND GLARE, RESPECTIVELY. THIRTY SUBJECTS (83%) REPORTED COMPLETE SPECTACLE INDEPENDENCE. THE TECNIS ZMB00 IS A BIFOCAL DIFFRACTIVE MIOL THAT HAS BEEN STUDIED IN PRESBYOPIC PATIENTS WITH AND WITHOUT CATARACT. THESE STUDIES HAVE SHOWN THAT THIS MIOL HAS PROVIDED SATISFACTORY VISION AT DISTANCE, INTERMEDIATE, AND NEAR AND CONTRAST SENSITIVITY (CS) UNDER PHOTOPIC AND MESOPIC CONDITIONS. MOST PATIENTS WHO RECEIVED THIS MIOL HAVE ALSO REPORTED HIGH RATES OF SPECTACLE INDEPENDENCE AND SATISFACTION. HOWEVER, NO PREVIOUS STUDY OF THIS MIOL HAS SIMULTANEOUSLY PRESENTED DATA ON CS WITH AND WITHOUT GLARE UNDER DIFFERENT LIGHT CONDITIONS. KAMIYA ET AL12 REVIEWED 50 CASES OF MIOL EXPLANTATION AND IDENTIFIED DECREASED CS AND THE PRESENCE OF GLARE AND OTHER PHOTIC PHENOMENA AS THE MOST COMMON REASONS FOR THE EXPLANTATION. THEREFORE, IT IS IMPORTANT TO INVESTIGATE THE EFFECTS OF GLARE ON THE CS OF THE ZMB00 UNDER DIFFERENT LIGHT CONDITIONS. THE CURRENT STUDY EVALUATED THESE ASPECTS OF VISUAL PERFORMANCE AND THE EASE WITH WHICH PATIENTS PERFORMED DAILY TASKS AFTER BILATERAL IMPLANTATION OF THE ZMB00. THE STUDY ALSO COMPARED THE RESULTS BETWEEN PATIENTS WHO UNDERWENT PRESBYOPIC LENS EXCHANGE AND CATARACT SURGERY TO ASSESS THE DIFFERENCE IN LEVEL OF SATISFACTION AND BETWEEN THE 3- AND 6-MONTH POSTOPERATIVE TIME POINTS TO ASSESS THE SPEED OF RECOVERY. THIS PROSPECTIVE CASE SERIES INCLUDED PATIENTS WHO UNDERWENT CATARACT SURGERY OR REFRACTIVE LENS EXCHANGE WITH BILATERAL IMPLANTATION OF THE ZMB00 MIOL BETWEEN AUGUST 2012 AND APRIL 2014 AT THE HONG KONG SANATORIUM AND HOSPITAL. AT THE 6-MONTH VISIT, 33 SUBJECTS (92%) WERE SATISFIED/VERY SATISFIED WITH THE UNCORRECTED VISION. THIRTY SUBJECTS (83%) ACHIEVED COMPLETE SPECTACLE INDEPENDENCE. A TOTAL OF 35 (97%), 24 (67%), AND 25 SUBJECTS (69%) REPORTED THAT IT WAS EASY/VERY EASY FOR THEM TO PERFORM DISTANCE, INTERMEDIATE, AND NEAR ACTIVITIES WITHOUT OPTICAL CORRECTION, RESPECTIVELY. OF 15 SUBJECTS, 13 (87%) WHO WERE DRIVERS REPORTED THAT IT WAS EASY/VERY EASY FOR THEM TO DRIVE AT NIGHT WITHOUT OPTICAL CORRECTION WHEREAS 1 (7%) REPORTED THAT IT WAS IMPOSSIBLE TO DO SO; 1 SUBJECT (7%) REPORTED THAT SHE DID NOT DRIVE AT THAT TIME. A TOTAL OF 21 (58%), 21 (58%), AND NO SUBJECTS (0%) REPORTED HALO, GLARE, AND DOUBLE IMAGES/ GHOSTING, RESPECTIVELY. FOR THOSE EXPERIENCING HALO AND GLARE, 20 (95%) AND 19 OF THEM (90%) REPORTED THAT IT WAS NOT BOTHERSOME/MILDLY BOTHERSOME. AMONG THE 4 (11%) AND 11 SUBJECTS (31%) WHO REPORTED DIFFICULTY IN SEEING DISTANCE AND READING SMALL PRINT, RESPECTIVELY ALL (100%) AND 9 OF THEM (82%) FOUND IT NOT BOTHERSOME/MILDLY BOTHERSOME. CONCLUSIONS: BILATERAL IMPLANTATION OF THE BIFOCAL MIOL IN PRESBYOPIC PATIENTS WITH OR WITHOUT CATARACT WAS SAFE IN SATISFACTORY VISION AND A HIGH RATE OF SPECTACLE INDEPENDENCE. HALOS AND GLARE WERE COMMON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727198 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention