BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 9359409 · Received November 21, 2019

    Report

    Report Number
    2648035-2019-01234
    Event Type
    Injury
    Date Received
    November 21, 2019
    Report Date
    November 5, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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

    DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS BETWEEN (B)(6) 2019. IF IMPLANTED, GIVE DATE: EXACT DATE NOT UNKNOWN, DATE PROVIDED AS (B)(6) 2019. IF EXPLANTED, GIVE DATE: N/A AS THE LENS REMAINS IMPLANTED THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED. THE SERIAL NUMBER FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE 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.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA/ ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS RECEIVED WHICH STATED THE INTRAOCULAR LENS (IOL) IMPLANTED INTO THE PATIENTS LEFT EYE WAS A NON-JOHNSON AND JOHNSON LENS. AS RESULT OF THIS INFORMATION, THIS COMPLAINT IS NO LONGER CONSIDERED A REPORTABLE EVENT. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH BILATERAL IMPLANTS WITH MODEL ZCB00 INTRAOCULAR LENSES (IOLS), HAS PERSISTENCE CME (CYSTOID MACULAR EDEMA). POST-OP VISUAL ACUITY WAS REPORTED AS 20/20 BUT NOW VISION IS COUNTING FINGERS. THE HEALTHCARE PROVIDER (HCP) INQUIRED IF THE CME IS POSSIBLY DUE TO AN ACRYLIC ALLERGY. VARIOUS TREATMENTS HAVE ALREADY BEEN ADMINISTERED. THE HCP IS WORKING CLOSELY WITH AN ALLERGIST. REQUESTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. NO ADDITIONAL INFORMATION PROVIDED. THIS REPORT CAPTURES THE EVENT FOR THE LEFT EYE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149617 TECNIS 1-PIECE MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention