BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRALASE

    MDR report key: 7077652 · Received December 2, 2017

    Report

    Report Number
    3006695864-2017-01242
    Event Type
    Malfunction
    Date Received
    December 2, 2017
    Date of Event
    November 3, 2017
    Report Date
    January 9, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    UDI-DI
    15050474534688
    PMA / PMN Number
    K060372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: IN THE INITIAL MDR AN INCORRECT MANUFACTURING LOCATION WAS REPORTED. THIS FIELD HAS BEEN CORRECTED FROM AMO PUERTO RICO, INC. TO AMO MANUFACTURING USA. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    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 SURGERY CENTER REPORTED SUCTION LOSS ON THE RIGHT EYE (OD) DURING SURGERY WITH AN INTRALASE PATIENT INTERFACE (PI) AFTER THE LASER FIRED. IT WAS NOTED THAT ONE (1) PROCEDURE WAS LOST AND THE SURGERY WAS COMPLETED SUCCESSFULLY USING A NEW PI. THERE WAS NO PATIENT INJURY REPORTED AND NO SURGICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856963 INTRALASE PATIENT INTERFACE HNO ABBOTT MEDICAL OPTICS PI-RET 15050474534688

    Patients

    Seq Age Sex Outcome Treatment
    1