BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR

    MDR report key: 10517896 · Received September 10, 2020

    Report

    Report Number
    3006695864-2020-00424
    Event Type
    Injury
    Date Received
    September 10, 2020
    Report Date
    October 9, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZS
    UDI-DI
    00(01)(21)5135
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL INFORMATION WAS PROVIDED. THE SURGERY CENTER INDICATED DISSATISFACTION WITH THE LASER EQUIPMENT AND THE TREATING SURGEON INDICATED HE HAS REVIEWED ABOUT 20 CASES THUS FAR AND REQUESTED SUPPORT. A J&J FIELD SERVICE REPRESENTATIVE VISITED THE SITE LOCATION AND PERFORMED AN UPGRADE ON THE IDESIGN EQUIPMENT. 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT : UNKNOWN. (B)(4). APPLICATION SUPPORT MANAGER (ASM) MET WITH THE PHYSICIANS AND REVIEWED PATIENT CHARTS. CUSTOMER WAS GIVEN AN IDESIGN OUTCOME SPREADSHEET BUT THEY DON¿T HAVE ENOUGH DATA TO COMPLETELY FILL OUT. THEY WILL BE RETREATED ONCE STABLE. MOST LIKELY WILL WAIT SEVERAL MONTHS. ASM VERIFIED ONE PATIENT WAS +1.75 BUT NOW RESOLVED TO +0.75. ASM WAS ABLE TO CONFIRM OVER MINUS AT THE IDESIGN ON 50% OF PEOPLE WE CAPTURED. ON AVERAGE OVER MINUS BY ABOUT 1.00 TO 1.50 DIOPTERS. ALSO LOOKED AT CHARTS THAT WERE OVERCORRECTED. DISCUSSED OPTIONS WITH USING PHYSICIAN ADJUSTMENTS WITH THE PHYSICIANS WHO CALCULATE ALL TREATMENTS AND EXPLAINED THE COMPENSATION FOR CHROMATIC ABERRATION AND OPTICAL INFINITY. ON THE PATIENTS IN QUESTION WITH OVERCORRECTIONS NO PHYSICIAN ADJUSTMENTS MADE AS HE RECALLED ¿NOT TO MAKE ANY ADJUSTMENTS¿ PER MESSAGING. WE DISCUSSED IN GREAT DETAIL THE ABILITY TO USE PHYSICIAN ADJUSTMENT BUT SOME DO SHOW A SIGNIFICANT DIFFERENCE BETWEEN MANIFEST REFRACTION (MR) AND IDESIGN AND THEY HAVE CONVERTED ABOUT 50% OF SURGICAL PATIENTS TO WAVESCAN ON LAST SURGERY DAY. THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER. THE FIELD SERVICE REPLACED THE COUPLERS C1/C2 AND LENS L3. REPLACED C1/C2 PAIR AND L3. FIELD SERVICE ENGINEER COMPLETED OPTICAL ALIGNMENT/CALIBRATION. 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 EXIMER 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

    CUSTOMER REPORTED 17 OVERCORRECTIONS. CUSTOMER MENTIONED GETTING OVERCORRECTIONS OF 1.00-1.50 DIOPTERS AND OCCASIONAL 2 DIOPTERS. THIS REPORT IS FOR THE EXCIMER. A SEPARATE REPORT WILL BE SUBMITTED FOR THE IDESIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982199 STAR EXCIMER LASER LZS JOHNSON & JOHNSON SURGICAL VISION, INC. 0030-2450 00(01)(21)5135

    Patients

    Seq Age Sex Outcome Treatment
    1 Other IDESIGN G301-4150