BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS ADVANCED INFUSION PACK

    MDR report key: 23380799 · Received October 24, 2025

    Report

    Report Number
    3012236936-2025-000265
    Event Type
    Injury
    Date Received
    October 24, 2025
    Date of Event
    September 30, 2025
    Report Date
    January 27, 2026
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES, RETURNED TO MANUFACTURER ON 10/29/2025. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: ONE (1) OPENED VRT-AI WAS RECEIVED WITHIN ZIPLOCK BAG; LOT NUMBER CANNOT BE CONFIRMED. DRAIN BAG WAS NOT INCLUDED, AND AN OPENED ALCON IRRIGATION SOLUTION BAG WAS INCLUDED. A VISUAL INSPECTION OF THE RETURNED PRODUCT REVEALED THAT THE ASPIRATION, IRRIGATION, AND IRRIGATION INLET TUBING WAS CUT. THE SPIKE DRIP CHAMBER WAS NOT ATTACHED OR INCLUDED. THE REPORTED EVENT CANNOT BE CONFIRMED AS IRRIGATION TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED PRODUCT. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: THE FOLLOWING TWO CODES WERE INADVERTENTLY LEFT OUT OF THE REPORT 3012236936-2025-0002653. HEALTH EFFECT - IMPACT CODE: 4625 - ADDITIONAL SURGERY. HEALTH EFFECT - CLINICAL CODE: 2523 - EYE BURN. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING INFUSION TUBING PACK, THERE WAS NO IRRIGATION DURING ULTRASOUND (US) AND A THERMAL BURN OCCURRED. THE ACCOUNT ALSO REPORTED THAT THE PATIENT'S WOUND WAS SUTURED AT THE END OF THE SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS FOUND THAT THE PATIENT'S INTRAOCULAR PRESSURE WAS LOW ONE DAY POST-OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532614 VERITAS ADVANCED INFUSION PACK UNIT, PHACOFRAGMENTATION HQC JOHNSON & JOHNSON SURGICAL VISION, INC. VRT-AI 60613930 35050474700902

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention