BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIQUID OPTICS INTERFACE, SIZE 14, GEN2

    MDR report key: 10400074 · Received August 13, 2020

    Report

    Report Number
    3005675890-2020-00037
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Date of Event
    March 12, 2020
    Report Date
    October 29, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    OOE
    UDI-DI
    05050474609761
    PMA / PMN Number
    K121091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IN REVIEW, OF MEDWATCH 3005675890-2020-00037 AND PER NEW INFORMATION RECEIVED, THIS EVENT HAS BEEN ASSESSED AS NOT REPORTABLE. THE LIQUID OPTICS INTERFACE (LOI) WAS PLACED ON THE PATIENT'S EYE; HOWEVER, THE LOI WOULDN'T FIT ON THE PATIENT EYE AND WAS REPLACED. THE LOI WAS CONTAMINATED DUE TO BEING IN CONTACT WITH THE PATIENT'S EYE AND COULD NOT BE REUSED. THERE WAS NO SEAL THAT APPEARED BROKEN OUT OF THE BOX BEFORE IT WAS HANDED TO THE STERILE FIELD AS INDICATED IN THE INITIAL REPORT. THERE WILL BE NO MORE INFORMATION PROVIDED FOR MFG REPORTING NO. 3005675890-2020-00037. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE SURGERY CENTER REPORTED THAT THE LIQUID OPTIC INTERFACE (LOI) WAS NOTED TO BE CONTAMINATED AS THE SEAL APPEARED BROKEN OUT OF THE BOX BEFORE IT WAS HANDED TO THE STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868835 LIQUID OPTICS INTERFACE, SIZE 14, GEN2 CATALYS OOE JOHNSON & JOHNSON SURGICAL VISION, INC. 0180-1401 11677615 05050474609761

    Patients

    Seq Age Sex Outcome Treatment
    1