BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPACT INTUITIV CONSOLE

    MDR report key: 9337408 · Received November 18, 2019

    Report

    Report Number
    3006695864-2019-00905
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    October 14, 2019
    Report Date
    November 5, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    UDI-DI
    05050474573628
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: IN INITIAL REPORT, THE MANUFACTURING DATE WAS REPORTED AS 8/22/2017. THE CORRECT DATE IS 7/11/2017. 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

    THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER. THE FIELD SERVICE FOUND NO ISSUES WITH THE UNIT. A FIELD SERVICE CHECKLIST WAS PERFORMED. THE UNIT COMPLIED WITH ALL FACTORY SETTINGS. 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 · 1

    THE SURGEON REPORTED THAT DURING CATARACT SURGERY ON (B)(6) 2019, ONCE HE APPLIED THE PHACO TIP TO THE PATIENT'S LEFT EYE HE IMMEDIATELY SAW A WHITE PLUME APPEAR AND REMOVED THE TIP. THE PATIENT REQUIRED A SINGLE FIGURE 8 SUTURE FOLLOWING THE CORNEAL BURN. THE SURGEON REPORTED THAT THE EVENT MAY HAVE BEEN DUE TO PHYSICIAN TECHNIQUE, BUT HE COULD NOT CONFIRM THIS. ON (B)(6) 2019, A SECONDARY PROCEDURE WAS PERFORMED ON THE LEFT EYE BY APPLYING AN ADDITIONAL SINGLE FIGURE 8 SUTURE OVER THE INCISION. THE PATIENT IS STILL HEALING. THIS REPORT IS FOR THE COMPACT INTUITIV PHACO SYSTEM. AN ADDITIONAL REPORT IS BEING SUBMITTED FOR THE 21 GAUGE LAMINAR PHACO TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129121 COMPACT INTUITIV CONSOLE COMPACT INTUITIV HQC JOHNSON & JOHNSON SURGICAL VISION, INC. SCP680300 05050474573628

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention PHACO TIP| PHACO TIP