BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK_PHACO HANDPIECE

    MDR report key: 24566115 · Received March 11, 2026

    Report

    Report Number
    3012236936-2026-000064
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    February 13, 2026
    Report Date
    March 11, 2026
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4, A5, AND A6: UNKNOWN/ NOT PROVIDED. 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 E1, TELEPHONE NUMBER, (B)(6). 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THEIR NURSE USED A WRENCH TO TIGHTEN THE PHACO TIP TO THE HANDLE, WHICH CAUSED SEVERAL FLECKS OF TITANIUM ALLOY TO BE RELEASED INTO THE PATIENT'S RIGHT EYE. THE SURGEON, INDICATED THAT MOST OR ALL OF THE TITANIUM PIECES WERE LIKELY REMOVED, THOUGH THERE IS A POSSIBILITY THAT SOME FRAGMENTS MAY REMAIN IN THE EYE. THE PATIENT WAS INFORMED OF THE INCIDENT. AS OF ONE WEEK AFTER THE SURGERY, THE PATIENT HAS NOT REPORTED ANY ADVERSE VISUAL EVENTS, RETAINS 20/20 VISION, AND EXHIBITS NO SIGNS OF ATYPICAL INFLAMMATION. FOLLOW UP INFORMATION WAS RECEIVED NOTING THAT THE SERIAL NUMBER OF THE HANDPIECE IS UNKNOWN, THE LOT NUMBER OF THE PHACO TIP IS POSSIBLY 5871856, AND THE PRODUCTS INVOLVED ARE UNAVAILABLE FOR RETURN. ADDITIONAL PATIENT DEMOGRAPHIC DETAILS, INCLUDING WEIGHT, RACE, AND ETHNICITY, ARE NOT KNOWN. NOTE: THIS REPORT IS AGAINST THE HANDPIECE. A SEPARATE REPORT WILL BE FILED AGAINST THE TIP AND WRENCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627580 UNK_PHACO HANDPIECE UNIT, PHACOFRAGMENTATION HQC AMO MANUFACTURING USA, LLC UNKNOWN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female TIP, WRENCH.