BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR

    MDR report key: 10314235 · Received July 23, 2020

    Report

    Report Number
    3006695864-2020-00354
    Event Type
    Injury
    Date Received
    July 23, 2020
    Date of Event
    June 30, 2020
    Report Date
    October 29, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZS
    UDI-DI
    00(01)(21)5056
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    SEX/GENDER: UNKNOWN/ NOT PROVIDED. (B)(6). (B)(4). INVESTIGATION RESULTS THE LASER SYSTEM, MODEL STAR, WAS EXAMINED AND TESTED AT THE CUSTOMER LOCATION BY AN JJSV FIELD SERVICE SPECIALIST (FSS). THE FSS REPLACED CHAIR MAINS CABLE. REPLACED VACUUM PILLOW LINE TUBING. RAN A CHECK DISK ON THE HARD DRIVE, FIXED ERRORS AS A RESULT. STARTED THE SYSTEM A NUMBER OF TIMES, ALL WENT OK. LASTLY WAS CHECKED THE SYSTEM PERFORMANCE. SYSTEM MEETS JOHNSON AND JOHNSON VISION SPECIFICATIONS. A RECORD REVIEW WAS PERFORMED. A PRODUCT DEFICIENCY REVIEW WAS PERFORMED AND THERE IS NO PRODUCT DEFICIENCY IDENTIFIED. A DOCUMENT, SERVICE HISTORY, AND TRENDING WAS REVIEWED. THERE IS NOT A RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. A LABELING REVIEW WAS CONDUCTED; THE OPERATOR MANUAL FOR THE SYSTEM WAS REVIEWED AND FOUND TO INCLUDE ADEQUATE INSTRUCTIONS FOR USE, WARNINGS AND OPERATIONAL ERRORS. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR STAR LASER SYSTEM SHOWED THAT THERE WERE NO ISSUES OR NON-CONFORMITIES. THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. MANUFACTURING HAS BEEN RULED OUT AS A POTENTIAL CAUSE FOR THE REPORTED ISSUE. BASED ON THE INVESTIGATION RESULTS, NO CORRECTIVE ACTION HAS BEEN ISSUED. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINTS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TREATMENT WITH EXCIMER LASER SYSTEM, MACHINE GAVE A BED NOT IN LOCKED POSITION ERROR FOR TWENTY SECONDS DURING THE PROCEDURE OF THE FIRST EYE OF THE PATIENT. AFTER FOLLOW-UP WE LEARNED THAT THIS ERROR WAS FOLLOWED BY NUMEROUS OF OTHER DIFFERENT UNKNOWN ERRORS. MOREOVER SURGEON WAS UNABLE TO GET THE LASER BACK FUNCTIONING AND HAD TO ABANDON THE TREATMENT. THE PATIENT WAS RELEASED AND SENT HOME WITH A BANDAGED CONTACT LENS ON THE EYE. ROUTINE EYE DROPS WERE GIVEN FOR FOUR DAYS. A NEW TREATMENT WAS PERFORMED FEW DAYS LATER AND ALL WENT WELL. SURGEON EXPECTED A NORMAL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780870 STAR EXCIMER LASER LZS JOHNSON & JOHNSON SURGICAL VISION, INC. 0030-2505 00(01)(21)5056

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention