BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4 IR

    MDR report key: 11704418 · Received April 21, 2021

    Report

    Report Number
    3006695864-2021-07544
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    February 26, 2021
    Report Date
    April 21, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    LZS
    UDI-DI
    05050474573413
    PMA / PMN Number
    P910062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021, A SURGEON PERFORMED A BILATERIAL PHOTOREFRACTIVE KERATECTOMY (PRK) ON A MALE PATIENT WITH LOW MYOPE USING THE VISX STAR EXCIMER LASER SYSTEM. THE PATIENT PRESENTED SUPERIOR STROMAL HAZINESS IN BOTH EYES (OU) POST TREATMENT. THE LEFT EYE (OS) WAS WORSE THAN THE RIGHT EYE (OD). THE PATIENT HAD APPEARANCE OF DIFFUSE LAMELLAR KERATITIS (DLK). IT WAS STATED THE PATIENT WAS ASYMPTOMATIC AND THE REST OF THE EXAM WAS UNREMARKABLE. ON (B)(6) 2021 IT WAS CONFIRMED THAT THE PATIENT WAS TREATED WITH INCREASED TOPICAL STEROID DROPS. THE PATIENT HAS RECOVERED AND IS DOING GREAT. VISION IS 20/30 OD AND 20/60 OS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601429 STAR S4 IR EXCIMER LASER SYSTEM LZS AMO MANUFACTURING USA, LLC 0030-4864 05050474573413

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention