BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT INTUITIV CONSOLE

    MDR report key: 8086817 · Received November 19, 2018

    Report

    Report Number
    3006695864-2018-02145
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    October 30, 2018
    Report Date
    November 5, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    HQC
    UDI-DI
    05050474573628
    PMA / PMN Number
    K060366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IN INITIAL REPORT, THE DEVICE MANUFACTURER DATE WAS INADVERTENTLY PROVIDED AS 7/28/2016, HOWEVER, THE CORRECT MANUFACTURER DATE IS 04/2016. A RECORD REVIEW WAS PERFORMED. A PRODUCT DEFICIENCY REVIEW WAS PERFORMED AND THERE IS NO PRODUCT DEFICIENCY IDENTIFIED. A DOCUMENT, SERVICE HISTORY, AND TRENDING WAS REVIEWED. THERE IS NOT A RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATION ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. A LABELING REVIEW WAS CONDUCTED; THE OPERATOR MANUAL FOR THE SYSTEM WAS REVIEWED AND FOUND TO INCLUDE ADEQUATE INSTRUCTIONS FOR USE, WARNINGS AND OPERATIONAL ERRORS. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR COMPACT INTUITIVE SYSTEM SHOWED THAT THERE WERE NO ISSUES OR NON-CONFORMITIES. MANUFACTURING HAS BEEN RULED OUT AS A POTENTIAL CAUSE FOR THE REPORTED ISSUE. NO CONCLUSIVE EVIDENCE IDENTIFIED FOR REPORTED ISSUE. THE SYSTEM WAS WORKING WITHIN SPECIFICATIONS. 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 NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PHACO TIP MODEL OPOF3020R, LOT NO. D34881, PHACO HANDPIECE, TUBING PACK. (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    DURING A CATARACT PROCEDURE, THE TIP BECAME OCCLUDED/CLOGGED USING A REUSABLE OPOF3020R- LAMINAR FLOW PHACO TIP. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THERE WAS A CLOGGED TIP DURING THE PROCEDURE, HENCE THE PROCEDURE WAS ABORTED AND NOT COMPLETED. THE SURGERY CENTER REPORTED 501 ERROR HAS BEEN OCCURRING FREQUENTLY AND IT IS UNKNOWN IF THE 501-ERROR OCCURRED DURING THE PROCEDURE. ALTHOUGH, THERE WAS AN ATTEMPT TO RESTART THE PHACOEMULSIFICATION UNIT, REPLACE THE PHACO HANDPIECE, AND REPLACE THE TUBING PACK, THE OCCLUSION WAS STILL PRESENT. THE PATIENT WAS SENT HOME. NO ADDITIONAL INFORMATION WILL BE PROVIDED BY THE SURGERY CENTER. NO PATIENT INJURY WAS REPORTED. THIS REPORT IS FOR THE PHACOFRAGMENTATION UNIT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE PHACO TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927562 COMPACT INTUITIV CONSOLE PHACOFRAGMENTATION UNIT HQC JOHNSON & JOHNSON SURGICAL VISION, INC SCP680300 05050474573628

    Patients

    Seq Age Sex Outcome Treatment
    1 PHACO TIP MODEL OPOF3020R, LOT NO. D34881.