BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_I/A HANDPIECE

    MDR report key: 19001469 · Received March 28, 2024

    Report

    Report Number
    3012236936-2024-00986
    Event Type
    Injury
    Date Received
    March 28, 2024
    Report Date
    May 3, 2024
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    PMA / PMN Number
    K981116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THROUGH FOLLOW UP IT WAS REPORTED TO JNJ THAT THE ISSUE OF THE INFECTIONS HAD BEEN RESOLVED BY THE CUSTOMER (INTERNALLY) AND THAT THE CAUSE WAS IDENTIFIED TO BE A NEW EMPLOYEE THAT WAS NOT FOLLOWING PROPER ASEPTIC PROTOCOLS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: IN FOLLOW UP #1 IT WAS REPORTED THAT THE ISSUE OF THE INFECTIONS HAD BEEN RESOLVED BY THE CUSTOMER (INTERNALLY) AND THAT THE CAUSE WAS IDENTIFIED TO BE A NEW EMPLOYEE THAT WAS NOT FOLLOWING PROPER ASEPTIC PROTOCOLS. IT WAS FAILED TO MENTION THAT THE J&J DEVICE IS NO LONGER A SUSPECT PRODUCT AS IT DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT BASED ON THE INFORMATION THAT WAS RECEIVED FROM THE CUSTOMER. THEREFORE, THE REPORTABILITY OF THIS CASE WAS DOWNGRADED, AND NO ADDITIONAL INFORMATION WILL BE PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A CASE OF INFECTION IN WHICH THE CUSTOMER HAS NOT BEEN ABLE TO ISOLATE THE SOURCE AND BELIEVE IT COULD BE THEIR SOLO IRRIGATION/ASPIRATION (I/A) HANDPIECE. PATIENT WAS PROVIDED MEDICAL TREATMENT FOR THE INFECTION AND IS EXPECTED TO HAVE A FULL RECOVERY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2241856 UNK_I/A HANDPIECE UNIT, PHACOFRAGMENTATION HQC JOHNSON & JOHNSON SURGICAL VISION, INC. UNK - I/A HANDPIECE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention