BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 9748751 · Received February 25, 2020

    Report

    Report Number
    9614546-2020-00075
    Event Type
    Injury
    Date Received
    February 25, 2020
    Date of Event
    January 22, 2020
    Report Date
    November 3, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    UDI-DI
    05050474559561
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DATE OF IMPLANT WAS (B)(6) 2019. THE FOLLOWING FIELD WAS UPDATED ACCORDINGLY: SECTION D6. IF IMPLANTED, GIVE DATE: (B)(6) 2019. SECTION D10. DEVICE AVAILABLE FOR EVALUATION? YES; RETURNED TO MANUFACTURER ON: 2/25/2020. SECTION H3. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE SAMPLE WAS RECEIVED IN A ZIP LOCK BAG AT THE MANUFACTURING SITE FOR EVALUATION. 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 RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH IN COMPLAINT SYSTEM REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER NUMBER. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    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)(6) AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN/ NOT PROVIDED. SEX/GENDER: UNKNOWN/ NOT PROVIDED. IF IMPLANTED, GIVE DATE: UNKNOWN, THE BEST ESTIMATE IS DECEMBER 2019. INITIAL REPORTER PHONE NUMBER: (B)(6). (B)(4). AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE POST OPERATION EXAMINATION, AFTER ONE (1) MONTH, THE PATIENT'S NEAR VISUAL ACUITY (VA) IS BAD (0.3-0.4)AND AUTOKERATOMETE (ARK) RESULT IS +0.75(S). THE DOCTOR ESTIMATED THAT THE POST-OP VA IS 1.0(MIN 0.8), BUT PATIENT¿S VA IS 0.6(2-4 LINE LOSS) AFTER SURGERY. REPORTEDLY, PER INTRAOCULAR LENS (IOL) MASTER (SRK/T) SUGGESTION, PATIENT CONDITION IS ALL OK WHICH THE DOCTOR AND PATIENT COMPLAINED ABOUT THIS ISSUE AND THE DOCTOR DECIDED TO EXPLANT THE LENS. IT WAS INDICATED THAT THE LENS WAS EXPLANTED ON (B)(6) 2020 AND A REPLACEMENT LENS, MODEL ZMB00 24.5 DIOPTER WAS USED. PATIENT'S OUTCOME WAS REPORTED TO BE AUTOKERATOMETE (ARK) RESULT: EMMETROPIA WAS REPORTED TO BE GOOD. VISUAL ACUITY: DISTANCE (1.0) / NEAR 33CM (0.8), WAS REPORTED TO BE GOOD. ALSO, IT WAS INDICATED THAT THE DOCTOR AND PATIENT ARE SATISFIED WITH THE RESULTS OF THE SURGERY WHICH ARE GETTING BETTER AND BETTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213686 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZLB00 05050474559561

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention