BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRALASE

    MDR report key: 7653333 · Received June 29, 2018

    Report

    Report Number
    2648035-2018-00929
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Report Date
    June 29, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS DURING 2018. LOT #: UNKNOWN, AS THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. UDI#: UNKNOWN SINCE PRODUCT LOT NUMBER WAS NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. 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. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE SURGERY CENTER REPORTED SUCTION LOSS ON LEFT EYE (OS) DURING RASTER PATTERN WITH AN INTRALASE PATIENT INTERFACE (PI) AFTER THE PATIENT WAS APPLANATED AND AFTER LASER FIRED. PER ACCOUNT, THE PATIENT WAS REPLANTED WITH THE SAME PI AND INTRALASE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS NOTED THAT PATIENT IS SCHEDULED BACK FOR FOLLOW-UP AND BEST CORRECT VISUAL ACUITY (BCVA) ON (B)(6) 2018. PRODUCT IS NOT EXPECTED TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491658 INTRALASE PATIENT INTERFACE HNO JOHNSON & JOHNSON SURGICAL VISION, INC. PI-RET UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1