BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_PHACO HANDPIECE

    MDR report key: 22155600 · 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
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4 SERIAL #: UNKNOWN/NOT PROVIDED. SECTION D4 MODEL # UNKNOWN/NOT PROVIDED. SECTION D4 CATALOG # UNKNOWN/NOT PROVIDED. SECTION D4 EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. SECTION D4 UDI #: 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 HANDPIECE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE 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. 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 HANDPIECE. A SEPARATE REPORT WILL BE FILED AGAINST THE VERITAS CONSOLE AND THE PHACO TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550578 UNK_PHACO HANDPIECE UNIT, PHACOFRAGMENTATION HQC AMO MANUFACTURING USA, LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention VERITAS CONSOLE, PHACO TIP