BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 5388522 · Received January 25, 2016

    Report

    Report Number
    3006695864-2016-00086
    Event Type
    Injury
    Date Received
    January 25, 2016
    Date of Event
    December 25, 2015
    Report Date
    March 22, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). FIELD SERVICE SPECIALIST VISITED THE ACCOUNT AFTER THE EVENT AND FOUND THAT Z GALVO POSITION CHECK ERROR IS CLEARED BY ENCODER ALIGNMENT FOLLOWED BY Z SCALE AND BASELINE OFFSET CALIBRATIONS. SEVERAL BURN-IN TESTS WERE PERFORMED AND NO ERRORS WERE OBSERVED. DEVICE WAS WITHIN SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: A REVIEW OF THE RECORDS RELATED TO THIS EQUIPMENT SHOWS A MECHANICAL FAILURE. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. THERE IS NOT A RECOGNIZABLE ADVERSE TREND BASED ON THE TREND REVIEW AND RISK EVALUATION. EQUIPMENT LABELING PROVIDES POTENTIAL ADVERSE EFFECTS THAT CAN BE CAUSED BY THE SURGICAL/TREATMENT PROCEDURE BEING PERFORMED. THE OPERATOR MANUALS FOR THE EQUIPMENT WERE REVIEWED AND DETERMINED TO INCLUDE ADEQUATE WARNINGS AND PRECAUTIONS FOR MEDICAL COMPLICATIONS. THERE WAS NO PRODUCT DEFICIENCY IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RING TREATMENT SYSTEM HAD A Z GALVO POSITION CHECK ERROR IN THE LAST 3 SECONDS. TREATMENT CAN NOT BE FINISHED THAT DAY AND PATIENT RETURNED NEXT DAY TO COMPLETE PROCEDURE. THE BELIEVES IT WAS CAUSED BY THE INTRALASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48248 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005K

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention