BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS ADVANCED INFUSION PACK

    MDR report key: 13699591 · Received March 8, 2022

    Report

    Report Number
    3012236936-2022-00578
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    February 3, 2022
    Report Date
    March 8, 2022
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    UDI-DI
    35050474700902
    PMA / PMN Number
    K203060
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE WAS DISCARDED AT THE SITE; THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: A REVIEW OF THE RECORDS RELATED TO THIS EQUIPMENT MEETS MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS AT THE TIME OF PRODUCT RELEASE. 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 ANTERIOR CHAMBER BECAME UNSTABLE AND POSTERIOR CAPSULE RUPTURED AFTER PRIMING DURING IRRIGATION/ASPIRATION DURING PROCEDURE (PRIOR TO LENS INSERTION) DESPITE OF VRT-AI PRESSURIZED INFUSION FUNCTION BEING ACTIVE. SURGEON USED ANTERIOR-VITRECTOMY CUTTER TO TREAT VITREOUS AND LENS WAS FIXED OUT-OF-THE-BAG. THERE WAS NO ISSUE INSERTING THE TUBING PACK INTO THE SYSTEM. THE SURGEON ALLEGED THAT THE ANTERIOR CHAMBER WAS STABLE DURING PHACO PROCEDURE, BUT POSTERIOR CAPSULE RAISED DURING IRRIGATION/ASPIRATION, AND HE IMMEDIATELY ATTEMPTED TO APPLY REFLUX, BUT IT RUPTURED. THERE WAS NOT MUCH REMAINING AMOUNT IN THE BALANCED SALT SOLUTION (BSS) BOTTLE WHEN THE ISSUE OCCURRED. PER CUSTOMER THE LOW AMOUNT OF BSS IN THE BOTTLE AND USE OF VRT-AI'S PRESSURIZED INFUSION FUNCTION COULD HAVE AFFECTED THE EVENT. PROCEDURE WAS COMPLETED WITH 20 MINUTES DELAY. INCISION WAS ENLARGED FROM 2.4MM TO 2.8MM. VITRECTOMY WAS PERFORMED. REPORTEDLY THE LENS WAS CHANGED FROM ZCB00V TO PN6A. THERE WAS NO MEDICATION PRESCRIBED. THE PATIENT HAS RECOVERED. THE PRODUCT WAS USED FOR A PATIENT WITH INFECTIOUS DISEASE, AND IT WAS DISCARDED AT CUSTOMER SITE. NO SAMPLE WILL BE RETURNED FOR INVESTIGATION. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1856595 VERITAS ADVANCED INFUSION PACK UNIT, PHACOFRAGMENTATION HQC JOHNSON & JOHNSON SURGICAL VISION, INC. VRT-AI 60304175 35050474700902

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention VERITAS CONSOLE (SN202110293), ELLIPS FX HANDPIECE