BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDESIGN ADVANCED WAVESCAN STUDIO

    MDR report key: 19923776 · Received August 6, 2024

    Report

    Report Number
    3012236936-2024-000219
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    January 26, 2023
    Report Date
    September 17, 2024
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    LZS
    UDI-DI
    05050474591912
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT EVALUATED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: IN THE INITIAL REPORT, THE MANUFACTURER DATE PROVIDED WAS INADVERTENTLY REPORTED AS 12/23/2015, HOWEVER THE CORRECT DATE IS 01/19/2016. ADDITIONAL INFORMATION: MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    AS PART OF A STUDY, PATIENT HAD SURGERY FOR MONOVISION TREATMENT. PATIENT CONSISTENTLY COMPLAINED OF BLURRY VISION IN THE LEFT EYE (OS), DIFFICULTY FOCUSING, AND DECREASED VISION, WITH THE COMPLAINTS WORSENING OVER TIME. AFTER EXPERIENCING THESE SYMPTOMS FOR OVER SIX MONTHS, THE PATIENT PREFERRED SURGICAL INTERVENTION. THE SURGEON CHOSE TO PROCEED WITH THE SURGERY USING THE WAVELIGHT LASER, LEADING TO THE PATIENT'S EXIT FROM THE STUDY. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE I DESIGN. A SEPARATE REPORT WILL BE FILED AGAINST THE STAR LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1573204 IDESIGN ADVANCED WAVESCAN STUDIO EXCIMER LASER SYSTEM LZS AMO MANUFACTURING USA, LLC G300 05050474591912

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention STAR LASER SERIAL NUMBER: (B)(6).