BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS VISION SYSTEM

    MDR report key: 24007644 · Received January 8, 2026

    Report

    Report Number
    3012236936-2026-000012
    Event Type
    Injury
    Date Received
    January 8, 2026
    Date of Event
    December 11, 2025
    Report Date
    February 9, 2026
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    UDI-DI
    5050474700864
    PMA / PMN Number
    K203060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION A2, AGE AT TIME OF THE EVENT: 79 YEARS. SECTION A2, DATE OF BIRTH: 10/18/1946. SECTION A3, GENDER: FEMALE. SECTION A5, ETHNICITY: NOT HISPANIC/LATINO. SECTION A5, RACE: WHITE. IT WAS REPORTED THAT PATIENT'S LEFT EYE WAS AFFECTED AND SUTURES WERE REQUIRED. PATIENT WAS STABLE POSTOPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2 A3, A4 AND A5: UNKNOWN/ NOT PROVIDED. SECTION D4: SERIAL #: UNKNOWN/NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. SECTION D4: UDI #: A COMPLETE UDI # IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THE DEVICE IS NOT IMPLANTABLE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE DEVICE IS NOT IMPLANTABLE. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY RECORD AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DOCTOR EXPERIENCED A WOUND BURN WHILE USING THE VERITAS DEVICE WITH ASPIRATION/IRRIGATION (AI) TUBING. NO ADDITIONAL INFORMATION REGARDING PATIENT IMPACT OR DEVICE MALFUNCTION WAS PROVIDED. NOTE: THIS REPORT IS AGAINST THE VERITAS CONSOLE. A SEPARATE REPORT WILL BE FILED AGAINST THE AI TUBING, HANDPIECE AND TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62547 VERITAS VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC JOHNSON & JOHNSON SURGICAL VISION, INC. VRT680300 5050474700864

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Other AI TUBING, HANDPIECE AND TIP.