BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISX EXCIMER LASER SYSTEM

    MDR report key: 13602782 · Received February 25, 2022

    Report

    Report Number
    3012236936-2022-00479
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Date of Event
    January 30, 2022
    Report Date
    February 25, 2022
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    LZS
    UDI-DI
    05050474573512
    PMA / PMN Number
    P930016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER TELEPHONE NUMBER: (B)(6) DEVICE EVALUATION : FIELD SERVICE SPECIALIST VISITED THE ACCOUNT AND WAS ABLE TO COMPLETE A SYSTEM SERVICE. DEVICE FAILED TO FUNCTION AS INTENDED. PROBLEM WAS RESOLVED. MANUFACTURING RECORD EVALUATION: BASED ON THE MANUFACTURING RECORDS REVIEW, AND HISTORICAL COMPLAINT REVIEW, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. NO NONCONFORMITY REPORT, DOCUMENTATION OR LABELING CHANGES, AND ESCALATIONS ARE REQUIRED. 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.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER TELEPHONE NUMBER: (B)(6). DEVICE EVALUATION: FIELD SERVICE SPECIALIST VISITED THE ACCOUNT AND WAS ABLE TO COMPLETE A SYSTEM SERVICE. DEVICE FAILED TO FUNCTION AS INTENDED. PROBLEM WAS RESOLVED. MANUFACTURING RECORD EVALUATION: BASED ON THE MANUFACTURING RECORDS REVIEW, AND HISTORICAL COMPLAINT REVIEW, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. NO NONCONFORMITY REPORT, DOCUMENTATION OR LABELING CHANGES, AND ESCALATIONS ARE REQUIRED. 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

    FIELD SERVICE ENGINEER VISITED SITE FOR ANOTHER ISSUE AND DURING SERVICE FOUND THE SYSTEM HAD INTERMEDIATELY MISS-FIRING. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    FIELD SERVICE ENGINEER VISITED SITE FOR ANOTHER ISSUE AND DURING SERVICE FOUND THE SYSTEM HAD INTERMEDIATELY MISS-FIRING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2359070 VISX EXCIMER LASER SYSTEM EXCIMER LASER SYSTEM LZS AMO MANUFACTURING USA, LLC 0030-4966 05050474573512

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown