BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX EXCIMER LASER

    MDR report key: 1950486 · Received November 5, 2010

    Report

    Report Number
    3006695864-2010-00126
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 7, 2010
    Manufacturer
    AMO MANUFACTURING USA LLC
    Product Code
    LZS
    PMA / PMN Number
    K000327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS DESCRIBED TO BE RELATED TO IFS AS OPPOSED TO THE VISX OR WAVESCAN SYSTEMS. BRAND NAME: IFS; FEMTOSECOND LASER, MODEL# 20005K; SERIAL # (B)(4). PMA# K060372. A SERVICE WAS NOT REQUESTED BY THE CLINIC. A REVIEW OF THE IFS EQUIPMENT SERVICE HISTORY REVEALS THAT A PM WAS PERFORMED WITH NO ISSUES REPORTED.

    Additional Manufacturer Narrative · 1

    EQUIPMENT SERVICE WAS NOT REQUESTED BY THE CLINIC. A REVIEW OF THE EQUIPMENT SERVICE HISTORY REVEALS THAT THE LAST SERVICE ON THE EXCIMER WAS PERFORMED IN JUNE AND AT THAT TIME A BSS (BALANCED SALT SOLUTION) SPLASH WAS FOUND ON THE OPTICS. THE OPTICS WERE CLEANED. NO OTHER ISSUES WERE NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). MFG DATE: JUNE 2008. PLACEHOLDER.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT ONE OF HIS LASER VISION CORRECTION PATIENTS EXPERIENCED A VISION LOSS OF FOUR LINES AFTER A LASER RETREATMENT. THE PATIENT REPORTEDLY IS NOT ABLE TO WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISX EXCIMER LASER LZS AMO MANUFACTURING USA LLC STAR S4 IR, CE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other