BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE SYSTEM, FUSION PUMP

    MDR report key: 15602080 · Received October 13, 2022

    Report

    Report Number
    3012236936-2022-02593
    Event Type
    Injury
    Date Received
    October 13, 2022
    Date of Event
    September 10, 2022
    Report Date
    December 20, 2022
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    UDI-DI
    05050474534445
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. IT WAS ALSO REPORTED BY THE DOCTOR THAT THE DIRECTION FOR USE (DFU) REGARDING THE HANDPIECE CLEANING/STERILIZATION WERE NOT FOLLOWED IN REGARDS OF THE FLUSHING (THE FLUSH WAS PERFORMED AFTER REMOVING THE TIP AND SLEEVE). THE ACCOUNT ALSO ADMITTED THE RE-USE OF THE OPO71 TUBING DURING THE THREE PROCEDURES WHEN THE TUBING IS LABELED AS SINGLE USE ONLY. THE DOCTOR UNDERSTANDS THE POSSIBILITY THAT THE RE-USE OF THE DEVICES MAY HAVE CAUSED THE EVENT. NO FURTHER INFORMATION WAS PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE DATE OF EVENT WAS SEPTEMBER 10, 2022. PHACO TIP AND SLEEVE MODELS WERE (B)(6) AND (B)(6); THE LOT NUMBERS WERE UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: CODES 4112, 4248 AND 61 WERE ADDED TO SECTION H6 BASED ON COMPLETED PRODUCT INVESTIGATION. BASE ON FOLLOW UP IT WAS LEARNED THAT "THE HANDPIECE AND OPO71 WERE REUSED FOR THE THREE PROCEDURES; ONLY THE TIP AND SLEEVE WERE CHANGED". PER Z311152 REV B, DFU, FUSION DUAL PUMP PACK - OPO71 MULTI, "DO NOT RESTERILIZE AND DO NOT REUSE". "THE RESTERILIZATION/REPROCESSING OF AMO SINGLE USE MEDICAL DEVICES MAY RESULT IN PHYSICAL DAMAGE TO THE MEDICAL DEVICE, FAILURE OF THE MEDICAL DEVICE TO PERFORM AS INTENDED, AND PATIENT ILLNESS OR INJURY DUE TO INFECTION, INFLAMMATION, AND/OR ILLNESS DUE TO PRODUCT CONTAMINATION, TRANSMISSION OF INFECTION AND LACK OF PRODUCT STERILITY". BASED ON THE INFORMATION OBTAINED, THERE IS NO INDICATION OF PRODUCT MALFUNCTION OR PRODUCT DEFICIENCY. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINTS PER GLOBAL COMPLAINT TRENDING. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ENDOPHTHALMITIS OCCURRED ON A PATIENT 1 DAY POSTOPERATIVELY. SURGEON SUSPECTED OPO71 (NEXT GENERATION PHACO TUBING DP-PACK) AND HANDPIECE MAY HAVE CAUSED THE ISSUE. THERE WERE NO DETAILS ON THE MEDICATION PRESCRIBED FOR THE PATIENTS. PATIENTS WERE RECOVERING AFTER A WEEK. THIS EVENT WILL CAPTURE PATIENT 2 OUT OF 3 PATIENTS AND FOR THE TUBING PRODUCT. A SEPARATE REPORT IS BEING SUBMITTED FOR THE HANDPIECE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2566530 WHITESTAR SIGNATURE SYSTEM, FUSION PUMP UNIT, PHACOFRAGMENTATION HQC JOHNSON & JOHNSON SURGICAL VISION, INC. OPO71 60345759 05050474534445

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention HANDPIECE MODEL 690880