BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4 IR

    MDR report key: 11890022 · Received May 26, 2021

    Report

    Report Number
    3006695864-2021-07799
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    April 8, 2021
    Report Date
    June 21, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    LZS
    UDI-DI
    00(01)(21)5144
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H4. DEVICE MANUFACTURE DATE: THE MANUFACTURING DATE WAS NOTED AS JUL 30, 2005. THE CORRECT MANUFACTURING DATE IS: 09/18/2001. THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER (FSE). THE FSE REPLACED THE OPTICS, HOWEVER, IT WAS NOT RELATED TO THE ISSUE REPORTED. THE FSE COMPLETED EXCIMER STANDARD SERVICE CALL CHECKLIST. THE LASER IS OPERATING ACCORDING TO JOHNSON & JOHNSON SURGICAL 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 EXCIMER 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 THESE TYPES OF COMPLAINTS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER (FSE). THE FSE REPLACED THE OPTICS, HOWEVER, IT WAS NOT RELATED TO THE ISSUE REPORTED. THE FSE COMPLETED FEMTO STANDARD SERVICE CALL CHECKLIST. THE LASER IS OPERATING ACCORDING TO JOHNSON & JOHNSON SURGICAL VISION SPECIFICATIONS. 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 SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT WAS PRESENTED WITH A CENTRAL ISLANDS ON BOTH EYES (OU) AT A ONE WEEK POST-OPERATIVE EXAM. THE PATIENT¿S VISUAL ACUITY AT POST OP VISIT WAS 20/60. IT WAS REPORTED THE PATIENT¿S VISION WAS IMPROVING. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS DONE. PRE-OP REFRACTIVE ERROR: OD -8.25-0.25X102, 20/20. OS -8.00-0.75X080, 20/20. SEEN 4/16/21 FOR 1 WEEK POST OP OD+1.00-0.50X178 20/30, UNCORRECTED 20/40. OS+0.75-0.50X170 20/60, UNCORRECTED 20/70.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780031 STAR S4 IR EXCIMER LASER SYSTEM LZS AMO MANUFACTURING USA, LLC 0030-2450 00(01)(21)5144

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other