BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE SYSTEM, FUSION PUMP

    MDR report key: 13503282 · Received February 10, 2022

    Report

    Report Number
    3012236936-2022-00310
    Event Type
    Injury
    Date Received
    February 10, 2022
    Date of Event
    December 21, 2021
    Report Date
    September 27, 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
    LO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). DEVICE EVALUATION: PRODUCT IS NOT AVAILABLE FOR INVESTIGATION, THEREFORE NO TESTING COULD BE PERFORMED. THE REPORTED EVENT CANNOT BE CONFIRMED. FOR THIS LOT, ALL DEVICES MEET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS AT THE TIME OF PRODUCT RELEASE. NO RELATED DEVIATION, NCMR, NC OR CAPA WAS INITIATED DURING THE MANUFACTURING PROCESS OF THE REPORTED LOT#. ALL DEVICES MEET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS AT THE TIME OF PRODUCT RELEASE. 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. ADDITIONAL INFORMATION: CUSTOMER REPORTED THAT THEY DID THEIR RETROSPECTIVE INVESTIGATION AND THEY SUSPECT THE OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WHICH IS NOT A JOHNSON & JOHNSON SURGICAL VISION (JJSV) PRODUCT AND OUR OPO71 TUBING. ALTHOUGH THEY ALSO REPORTED THAT THEY AGREE THE TUBING WAS STERILE AND NOT IN DIRECT CONTACT WITH THE EYE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SECTION H6: AS PART OF AN INTERNAL REVIEW OF OUR MDRS IT WAS IDENTIFIED THAT THE CODE 4644 FOR MEDICAL INTERVENTION NEEDS TO BE ADDED IN THE REPORT. 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 TOPICAL, SYSTEMIC AND INTRAOCULAR TREATMENT WAS REQUIRED. THE MEDICATION PRESCRIBED BY DOCTOR WAS PART OF THE STANDARD OF CARE. THE LENS REMAINS IMPLANTED AND PATIENT IS BEING MONITORED. THERE HAS BEEN NO PATTERN OBSERVED BY THE DOCTOR IN THE REPORTED CASES AND THE CUSTOMER REPORTS THAT THERE IS NO ASSIGNABLE ROOT CAUSE OF THE UVEITIS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    DOCTOR REPORTED THAT PATIENT HAD SURGERY ON (B)(6) 2021 AND PRESENTED SIX DAYS POST TREATMENT WITH UVEITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72213 WHITESTAR SIGNATURE SYSTEM, FUSION PUMP UNIT, PHACOFRAGMENTATION HQC JOHNSON & JOHNSON SURGICAL VISION, INC. OPO71 60270118 05050474534445

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention