BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS3

    MDR report key: 6153398 · Received December 7, 2016

    Report

    Report Number
    3006695864-2016-00975
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    November 10, 2016
    Report Date
    December 7, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SENIOR FIELD SERVICE SPECIALIST (SR FSS) VISITED THE SITE AFTER THE EVENT AND RECEIVED A Z STEPPER ERROR MESSAGE. HE CHECKED THE SYSTEM ERROR LOG AND NOTICED THAT THEY GOT A Z STEPPER WARNING (B)(4) TIMES ON (B)(6) 2016 AND (B)(4) TIMES ON (B)(6) 2016. IN A FOLLOW UP SERVICE VISIT HE FOUND Z STEPPER OUT OF POSITION. HE PERFORMED UPDATE ON Z OFFSET CALIBRATION AND CUT THE GEL TO CHECK. NO PROBLEMS WERE FOUND. HE LOOKED AT THE ENCODER AND FOUND IT WAS DRIFTING. IN THE NEXT SERVICE CALL HE REPOSITIONED THE ENCODER AND REPLACED STEPPER MOTOR AND DRIVER, CALIBRATED SYSTEM AND TESTED IT. SYSTEM MEETS ALL ABBOTT SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ACCOUNT REPORTED THAT DURING TREATMENT SURGEON EXPERIENCED A CASE OF VERTICAL GAS BREAKTHROUGH. HE REPORTED THERE WAS ONE SPOT THE GAS SEEMED TO BE TRAVELING VERTICAL AND HE CONVERTED PATIENT TO PHOTOREFRACTIVE KERATECTOMY. SURGEON REPORTED THAT HE NOTICED THE GAS IN THE PREVIOUS (B)(4) EYES BUT HE WAS ABLE TO LIFT THE FLAPS AND EXCIMER LASER WERE COMPLETED. NO PATIENT INTERFACE IS BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803189 INTRALASE FS3 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20004

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PATIENT INTERFACE UNKNOWN LOT