BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNFOLDER PLATINUM 1 SERIES

    MDR report key: 21098980 · Received January 8, 2025

    Report

    Report Number
    3012236936-2025-000007
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    December 11, 2024
    Report Date
    January 7, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    KYB
    UDI-DI
    05050474540323
    PMA / PMN Number
    K081545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    . DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, IT HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS PREVIOUSLY REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) PLATINUM CARTRIDGES ARE LEAVING A FILMY OR STICKY IT WAS PREVIOUSLY REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) PLATINUM CARTRIDGES ARE LEAVING A FILMY OR STICKY SUBSTANCE ON THE BOTTOM SIDE OF THE LENS WHEN IMPLANTING. (MANUFACTURER REPORT NUMBER 3012236936-2024-00697). PRESENTLY, THE SURGEON HAS CONTINUED TO NOTICE THE FILMY SUBSTANCE FROM THE COATING ON THE LENS MORE AND MORE. THE JOHNSON AND JOHNSON ACCOUNT EXECUTIVE JOINED THE CUSTOMER FOR SEVERAL CASES AND NOTICED THE FILMY SUBSTANCE ON 8 CASES. THE FILMY SUBSTANCE GETS STUCK ON THE BOTTOM SIDE OF THE IOL AND THE SURGEON USES HIS IRRIGATION/ASPIRATION (I/A) TO CLEAR IT, REMOVE IT. THE JNJ ACCOUNT EXECUTIVE FOLLOWED WHAT THE TECHNICIANS WERE DOING, AND IT WAS NOTHING OUT OF THE ORDINARY. THE CUSTOMER USES HEALON OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WHILE LOADING THE IOL. IN A FEW CASES THEY TRIED FLUSHING THE CARTRIDGE WITH BALANCED SALT SOLUTION (BSS) PRIOR TO OVD TO SEE IF THAT WOULD FLUSH IT OUT. REPORTEDLY, THE CUSTOMER TRIED JUST ABOUT EVERYTHING. THE DOCTOR POINTED OUT THE SUBSTANCE WHICH WAS VISIBLE ON THE MONITOR IN THE OPERATING ROOM (OR) BUT NO PHOTOS OR VIDEOS WERE TAKEN. THERE WERE NO COMPLICATIONS SUCH AS CAPSULE TEAR, VITRECTOMY OR SUTURE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED. NOTE: THE PREVIOUS CASE IS (B)(6) MANUFACTURER REPORT NUMBER 3012236936-2024-00697. THE ADDITIONAL EIGHT CASES INCLUDING THIS ONE. CASE 1 (B)(6) MANUFACTURER REPORT NUMBER 3012236936-2025-0000030 CASE 2 (B)(6) MANUFACTURER REPORT NUMBER 3012236936-2025-0000067 CASE 3 (B)(6) MANUFACTURER REPORT NUMBER 3012236936-2025-0000068 CASE 4 (B)(6) MANUFACTURER REPORT NUMBER 3012236936-2025-0000069 CASE 5 (B)(6) MANUFACTURER REPORT NUMBER 3012236936-2025-0000070 CASE 6 (B)(6) MANUFACTURER REPORT NUMBER . CASE 7 (B)(6) MANUFACTURER REPORT NUMBER 3012236936-2025-0000074. CASE 8 (B)(6) MANUFACTURER REPORT NUMBER 3012236936-2025-0000076.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347569 UNFOLDER PLATINUM 1 SERIES LENS, GUIDE, INTRAOCULAR KYB AMO PUERTO RICO MFG. INC. 1MTEC30 CP15414 05050474540323

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown IOL ZCB00 21.5 DIOPTER