BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS VISION SYSTEM

    MDR report key: 22155605 · Received June 5, 2025

    Report

    Report Number
    3012236936-2025-000158
    Event Type
    Injury
    Date Received
    June 5, 2025
    Date of Event
    May 12, 2025
    Report Date
    June 5, 2025
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    UDI-DI
    05050474700864
    PMA / PMN Number
    K203060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2 , A4 AND A5: UNKNOWN/ NOT PROVIDED. D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THE DEVICE IS NOT IMPLANTABLE. D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE DEVICE IS NOT IMPLANTABLE. 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. H11: THROUGH FOLLOW UP IT WAS LEARNED THAT THE MOST PROBABLE CAUSE FOR THE WOUND BURN WAS AN OCCLUDED PHACO TIP DUE TO THE USE OF MAX ULTRASOUND BEFORE CLEARING OUT OVD. THE OCCLUDED PHACO TIP PREVENTED THE BALANCED SALT SOLUTION FROM COOLING THE TIP. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CASE IN THE MIDDLE OF SURGEON'S LINEUP, HE EXPERIENCED A WOUND BURN. HE INJECTED ADDITIONAL VISCOAT (OPHALMIC VISCOELASTIC BRAND) RIGHT BEFORE HE ENTERED THE EYE WITH THE PHACO NEEDLE, THEN PROCEEDED TO SCULPT IMMEDIATELY WITH THE MAX SET POWER (50) AND DIDN¿T CLEAR OUT ANY OPHTHALMIC VISCOSURGICAL DEVICE (OVD). A JNJ REP WAS AT SITE DURING THE SURGERY AND NOTICED THAT THE PHACO NEEDLE WAS NOT ASPIRATING DUE TO THE WHITE PLUME AND KNOWING HE JUST INJECTED ADDITIONAL DISPERSIVE OVD INTO THE EYE, SO THE REP INSTRUCTED HIM TO CLEAR OUT THE OVD BEFORE SCULPTING. HE SWITCHED TO HIS CHOP SETTING TO EVACUATE THE OVD FROM THE ANTERIOR SURFACE OF THE CATARACT AND THEN WENT BACK TO SCULPT. THE PHACO NEEDLE WAS ASPIRATING NORMALLY AT THAT TIME, SO HE PROCEEDED WITH THE CASE. AT THE END OF THE CASE, HE TRIED TO SEAL THE WOUND WITHOUT A SUTURE BUT WAS UNSUCCESSFUL. SO HE USED 3 SUTURES TO CLOSE THE WOUND AND PUT ON A DISPOSABLE CONTACT LENS TO KEEP IT HYDRATED. PATIENT WAS 20/30 DAY ONE POST-OP. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS AGAINST THE VERITAS CONSOLE. A SEPARATE REPORT WILL BE FILED AGAINST THE HANDPIECE AND THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551553 VERITAS VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC JOHNSON & JOHNSON SURGICAL VISION, INC. VRT680300 05050474700864

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention HANDPIECE, TIP