BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX EXCIMER LASER SYSTEM

    MDR report key: 12559061 · Received October 1, 2021

    Report

    Report Number
    2020664-2021-07595
    Event Type
    Injury
    Date Received
    October 1, 2021
    Report Date
    September 30, 2021
    Product Code
    LZS
    UDI-DI
    05050474573512
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OR DOB, WEIGHT, ETHNICITY: UNKNOWN/ NOT PROVIDED. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). MANUFACTURING RECORD REVIEW: A RECORD REVIEW WAS PERFORMED. A PRODUCT DEFICIENCY REVIEW WAS PERFORMED AND THERE IS NO PRODUCT DEFICIENCY IDENTIFIED. A DOCUMENT, LOT HISTORY, AND TRENDING WERE REVIEWED. THERE IS NOT A RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATION'S ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT THERE WERE NO ISSUES OR NON-CONFORMITIES. THE DEVICE 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 INFORMATION OBTAINED, PRODUCT MALFUNCTION AND PRODUCT DEFICIENCY CANNOT BE CONFIRMED. NO FURTHER INVESTIGATION IS REQUIRED. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS UNDERCORRECTION ISSUE. RE:+0.25/-3.00@15,VISUAL ACUITY 6/6. DOCTOR PERFORMED SUB-BOWMAN'S KERATOMILEUSIS (SBK) MICROKERATOME LASIK ON (B)(6) 2021. POST OP VISION ON (B)(6) 2021 UNAIDED VISUAL ACUITY IS 6/9 AND REFRACTION OF THE PATIENT IS -0.75@30 WITH 6/6 VISUAL ACUITY. DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. DOCTOR PERFORMED ENHANCEMENT SURGERY. VISION PRE-OPERATIVE: 6/6. VISION POST-OPERATIVE: 6/9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461492 VISX EXCIMER LASER SYSTEM EXCIMER LASER SYSTEM LZS 0030-4966 05050474573512

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention