BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRALASE

    MDR report key: 4962703 · Received August 4, 2015

    Report

    Report Number
    2648035-2015-00552
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Date of Event
    June 5, 2015
    Report Date
    July 10, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PATIENT INTERFACE (PI) SUCTION RING MAY LOSE SUCTION DURING A PROCEDURE. LABEL COPY STATES CORNEAL FIXATION VACUUM LOSS CAN OCCUR. THERE ARE SEVERAL FACTORS THAT MAY CONTRIBUTE TO SUCTION ISSUES SUCH AS DOCTOR'S TECHNIQUE IN APPLYING THE SUCTION RING TO THE CORNEA, DOCTOR'S TECHNIQUE IN SQUEEZING THE PI CLIP TO SECURE THE SUCTION RING TO THE PI CONE AND PATIENT ANATOMY AFFECTING THE INTERFACE BETWEEN THE PATIENT'S CORNEA AND THE SUCTION RING. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED SUCTION LOSS WHILE THE LASER FIRING WITH AN INTRALASE PATIENT INTERFACE (PI). THERE IS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507064 INTRALASE PATIENT INTERFACE HNO ABBOTT MEDICAL OPTICS PI-RET CM01483

    Patients

    Seq Age Sex Outcome Treatment
    1 FEMTO LASER SERIAL NUMBER (B)(4)