BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4 IR

    MDR report key: 11312215 · Received February 11, 2021

    Report

    Report Number
    3006695864-2021-07160
    Event Type
    Injury
    Date Received
    February 11, 2021
    Date of Event
    January 8, 2021
    Report Date
    April 21, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    LZS
    UDI-DI
    00(01)(21)3088
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: H4: DEVICE MANUFACTURE DATE, CORRECTED TO MAR 25, 1996. DEVICE EVALUATION: 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 VISX STAR 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 THIS TYPE OF COMPLAINTS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    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

    CUSTOMER REPORTED STAGE 2-3 DIFFUSE LAMELLAR KERATITIS (DLK) AND SOME DEGREE OF VISUAL LOSS. A FLAP LIFT AND RINSE WAS PERFORMED ON (B)(6) 2021. TOPICAL AND ORAL STEROIDS WERE PRESCRIBED. DLK WAS RESOLVED ON (B)(6) 2021. PRE OP - MANIFEST REFRACTION. OD: -1.00 + 0.50 X 100 20/20, OS: -1.00 + 0.50 X 80 20/20. CYCLOGENIC REFRACTION. OD: -0.75 SPH 20/20, OS: -0.75 SPH 20/20. POST OP REFRACTION. OD: 20/20. OS: 20/40 AS OF (B)(6) 2021 DID NOT REFRACT OS YET. THIS REPORT IS FOR THE EXCIMER LASER SYSTEM. A SEPARATE REPORT WILL BE FILED FOR THE FEMTO LASER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209827 STAR S4 IR EXCIMER LASER SYSTEM LZS AMO MANUFACTURING USA, LLC 0030-1479 00(01)(21)3088

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention IFS SERIAL NUMBER (B)(6)