BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 10418150 · Received August 17, 2020

    Report

    Report Number
    9614546-2020-00316
    Event Type
    Injury
    Date Received
    August 17, 2020
    Report Date
    October 29, 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
    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 NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    AGES/DATE(S) OF BIRTH: RANGE: 48¿74. GENDER(S)SEX(ES): FEMALE, N(%): 16 (76). DATE OF EVENT: UNKNOWN, NOT PROVIDED. CATALOG#: A COMPLETE CATALOG NUMBER IS UNKNOWN AS SERIAL NUMBERS WERE NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS SERIAL NUMBERS WERE NOT PROVIDED. SERIAL#: UNKNOWN, INFORMATION WAS NOT PROVIDED. UNIQUE IDENTIFIER: UDI# IS UNKNOWN AS THE SERIAL NUMBERS WERE NOT PROVIDED. IMPLANT DATE: UNKNOWN, INFORMATION WAS NOT PROVIDED. EXPLANT DATE: N/A (NOT APPLICABLE) AS THE DEVICES WERE NOT EXPLANTED. INITIAL REPORTER'S PHONE NUMBER: UNKNOWN, NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN, AS SERIAL NUMBERS WERE NOT PROVIDED. (B)(4). DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCTS WERE NOT RETURNED (THE LENSES REMAIN IMPLANTED). THE REPORTED EVENTS COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: A REVIEW OF THE RECORDS COULD NOT BE PERFORMED AS THE PRODUCT SERIAL NUMBERS WERE NOT PROVIDED. A SEARCH OF COMPLAINTS RELATED TO SERIAL NUMBERS CANNOT BE PERFORMED SINCE THE SERIAL NUMBERS ARE UNKNOWN. CONCLUSION: NO SAMPLES WERE RETURNED, AND SERIAL NUMBERS ARE UNKNOWN AN INVESTIGATION COULD NOT BE PERFORMED, AND NO MALFUNCTION IS CONFIRMED. CITATION: CHANG, J., S M; LIU, S., C T; NG, J., C M; MA, PL., (2020 ), MONOVISION WITH A BIFOCAL DIFFRACTIVE MULTIFOCAL INTRAOCULAR LENS IN PRESBYOPIC PATIENTS: A PROSPECTIVE, OBSERVATIONAL CASE SERIES, AM J OPHTHALMOL, 212(04), PP105¿115 ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: MONOVISION WITH A BIFOCAL DIFFRACTIVE MULTIFOCAL INTRAOCULAR LENS IN PRESBYOPIC PATIENTS: A PROSPECTIVE, OBSERVATIONAL CASE SERIES A STUDY WAS DONE TO REPORT THE VISUAL OUTCOMES AFTER BILATERAL IMPLANTATION OF BIFOCAL DIFFRACTIVE INTRAOCULAR LENS (IOLS) TARGETING MONOVISION. POSTOPERATIVELY, 11 PATIENTS REPORTED HALOS, 6 REPORTED GLARE, AND 5 REPORTED STARBURSTS. THERE ARE NO INDICATIONS OF INTERVENTIONS IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878663 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other