BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 8542087 · Received April 23, 2019

    Report

    Report Number
    2648035-2019-00484
    Event Type
    Injury
    Date Received
    April 23, 2019
    Date of Event
    February 15, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474620605
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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

    IF EXPLANTED, GIVE DATE: NOT APPLICABLE, REMAINS IMPLANTED IN THE EYE. (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THE MODEL NUMBER (ZCB00) WAS ENTERED INADVERTENTLY ENTERED IN THE INITIAL EMDR REPORT WHICH IS INCORRECT. THE CORRECT DEVICE MODEL IS ''GCB00'' WHICH HAS BEING CORRECTED IN THIS SUPPLEMENTAL MDR REPORT. THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS 1-PIECE IOL, MODEL GCB00 THAT HAS A SIMILAR DEVICE, TECNIS 1-PIECE IOL MODEL PCB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. DEVICE EVALUATION: THE CLINICAL INVESTIGATION WILL BE COVERED UNDER THE CLINICAL STUDY FOR THIS DEVICE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT OF THE INTRAOCULAR LENS INTO THE PATIENT¿S LEFT EYE, INTRAOCULAR PRESSURE (IOP) SPIKED AT THE 1-DAY POST-OP VISIT. REPORTEDLY THERE WAS PATIENT COMPLICATION AND/OR RELATED INJURY, IOP SPIKE REQUIRING TREATMENT WAS NOT SIGHT THREATENING. THE LENS CURRENTLY REMAINS IMPLANTED IN THE PATIENT¿S LEFT EYE. THE PATIENT IS TAKING DIAMOX TO REDUCE THE IOP. SURGEON USES A WOUND ASSISTED TECHNIQUE FOR IMPLANTATION BUT DURING IMPLANTATION THE IOL POPPED FROM WOUND AND WAS ASSISTED IN TO THE ANTERIOR CHAMBER (AC) DURING INSERTION. THERE WAS NO PATIENT COMPLICATION AND/OR RELATED INJURY. PATIENT HAS RECOVERED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335761 TECNIS 1-PIECE MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. GCB00 05050474620605

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention