BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 5578135 · Received April 14, 2016

    Report

    Report Number
    3006695864-2016-00391
    Event Type
    Injury
    Date Received
    April 14, 2016
    Date of Event
    March 18, 2016
    Report Date
    April 14, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LASER MACHINE WAS EXAMINED AND TESTED AT THE CUSTOMER LOCATION BY AN ABBOTT FIELD SERVICE SPECIALIST (FSS).THE FSS FOUND THE OSCILLATOR SET POINT WAS AT 1.174 AS IT SHOULD HAVE BEEN BETWEEN 1.160 TO 1.167. IN ADDITION, THE FSS FOUND ONE OF THE INTERNAL FANS ON THE CHILLER WAS NOT RUNNING. THE OSCILLATOR SET POINT WAS ADJUSTED AND THE CHILLER ASSEMBLY WAS REPLACED. FURTHERMORE, A PREVENTATIVE MAINTENANCE (PM) WAS PERFORMED. AS PART OF THE PM, THE OPTICS WAS CLEANED AND THE ENERGY WAS VERIFIED. THE FIELD SERVICE SPECIALIST (FSS) PERFORMED A CHECKLIST AND VERIFIED ALL MODES OF OPERATIONS. THE UNIT MEETS AMO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE SURGERY CENTER REPORTED THE LASER SYSTEM GENERATED LASER COOLING AND OSCILLATOR TEMPERATURE ERRORS PRIOR TO A SURGERY COMMENCING RESULTING IN THE LASER SYSTEM NOT WORKING PROPERLY. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THERE WAS A PATIENT ON THE TABLE WHEN THE LASER WENT DOWN AND THE PROCEDURE WAS ABORTED AND CONVERTED TO A PHOTOREFRACTIVE KERATECTOMY (PRK) TREATMENT. AT THE TIME OF THE EVENT, THERE WAS AN AMO CLINICAL DEVELOPMENT MANAGER (CDM) ON SITE. THE CDM VERIFIED THE AMP AND OSCBASEPLATE TEMPERATURES WERE WITHIN SPECIFICATIONS. SINCE THE LASER SYSTEM WAS NOT OPERATIONAL, THE REMAINING PATIENTS'' SCHEDULED WAS EITHER CANCELLED OR SOME PROCEDURES WERE CONVERTED TO THE PRK. THE SURGERY CENTER STATED THE PATIENT OUTCOME WAS GOOD AND THERE WERE NO ISSUES WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232373 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention PATIENT INTERFACE LOT NO. CA16072