BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITESTAR SIGNATURE SYSTEM, FUSION PUMP

    MDR report key: 23442137 · Received October 31, 2025

    Report

    Report Number
    3012236936-2025-000275
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    September 25, 2025
    Report Date
    February 10, 2026
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    UDI-DI
    35050474534446
    PMA / PMN Number
    K060366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9, DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9, DATE RETURNED TO MANUFACTURER: NOVEMBER 24, 2025. SECTION H3, DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: ANALYSIS OF THE PHOTO PROVIDED BY THE CUSTOMER REVEALED A TEAR IN THE TYVEK LID. A UNIT OF THE REPORTED OPENED OPO71 WAS RECEIVED WITHIN ORIGINAL PACKAGING CONFIRMING THE REPORTED LOT NUMBER. A VISUAL INSPECTION OF THE RETURNED PRODUCT REVEALED A LARGE TEAR IN THE TYVEK LID. THE REPORTED ISSUE WAS CONFIRMED. CONCLUSION: THE REPORTED COMPLAINT OF A DAMAGED CASING WAS CONFIRMED THROUGH THE INVESTIGATION. HOWEVER, THROUGH REVIEW OF THE MANUFACTURING PROCESS AND INSPECTION OF THE PRODUCTION AREA, NO ROOT CAUSE COULD BE FOUND FROM THE MANUFACTURING PROCESS. THE EVENT APPEARS TO BE ISOLATED, AS ONLY ONE COMPLAINT WAS REPORTED OUT OF (B)(4)UNITS SHIPPED BETWEEN JUNE 2023 AND DECEMBER 2025. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. . SECTION E1 - TELEPHONE NUMBER: (B)(6). 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 AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE REMOVING A FUSION OPO71 DOUBLE PUMP CARTRIDGE KIT FROM ITS BOX, THEY DISCOVERED A UNIT WITH A DAMAGED CASING, WHICH COMPROMISED THE STERILITY OF THE CONTENTS. THE CUSTOMER REQUESTED A REPLACEMENT FOR THE AFFECTED PRODUCT. THROUGH FOLLOW-UP WE LEARNED THAT PRODUCT WAS NOT USED IN THE PATIENT. THE EXTERNAL PACKAGING THAT WAS DELIVERED THE PRODUCT OPO71 WAS INTACT. PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT. CUSTOMER MENTIONED THAT WAS NOT ISSUE IN THE DELIVERY AS THE EXTERNAL PACKAGING WAS INTACT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2085090 WHITESTAR SIGNATURE SYSTEM, FUSION PUMP UNIT, PHACOFRAGMENTATION HQC AMO MANUFACTURING USA, LLC OPO71 60473931 35050474534446

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown