BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERITAS VISION SYSTEM

    MDR report key: 16919310 · Received May 12, 2023

    Report

    Report Number
    3012236936-2023-01207
    Event Type
    Malfunction
    Date Received
    May 12, 2023
    Date of Event
    April 18, 2023
    Report Date
    July 13, 2023
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    UDI-DI
    05050474700864
    PMA / PMN Number
    K203060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION DATA: AT THE TIME OF THE INITIAL MDR REPORTING FOLLOWING INFORMATION WAS MISSED INADVERTENTLY: SECTION B5: DURING THE FIELD SERVICE ENGINEER'S VISIT IT WAS LEARNT THAT PHACO MACHINE WAS THE PROBLEM AND NOT THE TUBING PACK. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    INFORMATION REQUESTED HOWEVER, NOT AVAILABLE AT THE TIME OF THIS REPORT. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). PRODUCT EVALUATION: WAS PERFORMED FOR THIS INCIDENT. SERVICE WAS ONSITE AND EVALUATED THE SYSTEM. SERVICE REPLACED PARTS. THE SYSTEM IS PERFORMING TO SPECIFICATION. MANUFACTURING RECORD REVIEW: A REVIEW OF THE RECORDS RELATED TO THIS EQUIPMENT THAT INCLUDED LABELING, MANUAL, TRENDING, AND RISK DOCUMENTATION REVIEWS WAS PERFORMED. EQUIPMENT LABELING PROVIDES POSSIBLE COMPLICATIONS THAT CAN BE CAUSED BY THE SURGICAL/TREATMENT PROCEDURE BEING PERFORMED. THE TREND REVIEW SHOWS THAT THERE IS NOT A RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. THERE WAS NO PRODUCT DEFICIENCY IDENTIFIED. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYSTEM HAD ERROR MESSAGE OF GAS FORCED INFUSION PRESSURE BEING TOO HIGH WHILE IN IRRIGATION ASPIRATION MODE. CUSTOMER REPLACED TUBING PACK, HOWEVER THE ISSUE WAS NOT RESOLVED. CUSTOMER UNCHECKED THE ADVANCED INFUSION SETTING, AND THE MACHINE WORKED IN GRAVITY MODE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 5 MINUTES DELAY. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167663 VERITAS VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC JOHNSON & JOHNSON SURGICAL VISION, INC. VRT680300 05050474700864

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown VRT-AI LOT 60372490