BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITESTAR SIGNATURE SYSTEM, FUSION PUMP

    MDR report key: 14780940 · Received June 22, 2022

    Report

    Report Number
    3012236936-2022-01650
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Date of Event
    May 26, 2022
    Report Date
    August 1, 2022
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. LOT NUMBER - UNKNOWN. UNIQUE IDENTIFIER (UDI) NUMBER - UNKNOWN. MEDICAL PRODUCT - WHITESTAR SIGNATURE PRO ((B)(4)), JNJ PHACO TIP (LOT 5185577), HEALON PRO (LOT UJ31556). IMPLANT DATE: OPO71 TUBING IS NOT AN IMPLANTABLE DEVICE. EXPLANT DATE: OPO71 TUBING IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. TELEPHONE NUMBER: (B)(6). THE OPO71 TUBING HAS NOT BEING RECEIVED. 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 EQUIPMENT 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THROUGH FOLLOW UP IT WAS LEARNT THAT THE FRAGMENTS WERE SEND BY THE CUSTOMER TO AN INDEPENDENT LABORATORY. THE FRAGMENTS HAVE BEEN CONFIRMED TO BE BONE FRAGMENTS AND WERE NOT PART OF ANY JOHNSON & JOHNSON DEVICE. IT APPEARS THAT THERE WAS SOME CROSS CONTAMINATION IN THE STERILIZING ROOM AS ORTHOPEDIC INSTRUMENTS ARE STERILIZED THERE AS WELL. NO FURTHER INFORMATION WAS PROVIDED. TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS CODES ADDED AS A RESULT OF THE NEW INFORMATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FOREIGN BODY WAS NOTICED IN THE SCULPT PHASE, PRIOR TO IOL (INTRAOCULAR LENS) IMPLANTATION. THIS WAS REMOVED WITH FORCEPS AND KEPT FOR ASSESSMENT AND THE PATIENT WAS UNAFFECTED WITH THE SURGERY BEING COMPLETED SUCCESSFULLY.. SEVERAL PRODUCTS WERE IN USE AT THE TIME AND THE CUSTOMER SUSPECTS THE MATERIAL TO HAVE COME FROM OPO TUBING SPIKE WHICH IS MADE FROM A WHITE PLASTIC MATERIAL. SUBSEQUENTLY ONE SURGEON HAS BEEN FLUSHING THE HANDPIECE FOR AN EXTRA PERIOD OF TIME PRIOR TO SURGERY AND DID NOT SEEN ANY PARTICLES SINCE THEN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289966 WHITESTAR SIGNATURE SYSTEM, FUSION PUMP UNIT, PHACOFRAGMENTATION HQC JOHNSON & JOHNSON SURGICAL VISION, INC. OPO71 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown