BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 8580455 · Received May 4, 2019

    Report

    Report Number
    9614546-2019-00409
    Event Type
    Injury
    Date Received
    May 4, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    UDI-DI
    05050474558984
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEW, IT WAS NOTED THAT THE INITIAL MDR REPORT HAD THE IMPLANT DATE (B)(6) 2018; HOWEVER, THE SUPPLEMENTAL REPORT INADVERTENTLY INDICATED THAT THE IMPLANT DATE LISTED IN THE INITIAL MDR REPORT WAS NOT CORRECT. THIS SUPPLEMENTAL REPORT IS TO CLARIFY THAT THE DATE OF IMPLANT OF (B)(6) 2018 WHICH WAS LISTED IN THE INITIAL REPORT WAS INDEED CORRECT. THE FOLLOWING FIELD WAS UPDATED ACCORDINGLY: SECTION D6. IF IMPLANTED, GIVE DATE: (B)(6) 2018. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON REVIEW OF THE FILE IT WAS NOTED THAT IN THE INITIAL MDR SECTION D6 WAS POPULATED WITH AN INCORRECT IMPLANT DATE. THE APPROPRIATE IMPLANT DATE IS (B)(6)2018. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED. H3 OTHER TEXT : PLACEHOLDER.

    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

    AGE/DATE OF BIRTH: UNKNOWN, INFORMATION NOT PROVIDED. DATE OF EVENT: EXACT DATE NOT PROVIDED ONLY MONTH AND YEAR, DECEMBER 2018. PHONE NUMBER: (B)(6). (B)(4). DEVICE EVALUATION: THE PRODUCT WAS RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION IN A LENS CASE. VISUAL INSPECTION WITH THE UNAIDED EYE SHOWS THE PRODUCT IS CUT IN PIECES, MOST PROBABLY TO MAKE EXPLANT POSSIBLE. CONSIDERING THE CONDITION OF THE LENS ADDITIONAL ANALYSIS IS NOT POSSIBLE. THE COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WAS REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH IN COMPLAINTS HISTORY REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER NUMBER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER CATARACT SURGERY, THE PATIENT COMPLAINED ABOUT VISION ACUITY DURING POST-OPERATIVE EXAMINATION, ESPECIALLY UNCOMFORTABLE AT DISTANCE VISION. DECISION WAS MADE TO EXCHANGE THE INTRAOCULAR LENS (IOL). REPORTEDLY, THE INCISION WAS ENLARGED TO REMOVE THE IOL FROM THE EYE, BUT NO SUTURES OR VITRECTOMY REQUIRED AND NO DELAY IN PROCEDURE WAS REPORTED. THE REPLACEMENT LENS WAS A ZLB00 23.0 DIOPTER LENS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373941 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZKB00 05050474558984

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention