BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRALASE

    MDR report key: 6860652 · Received September 12, 2017

    Report

    Report Number
    2648035-2017-01636
    Event Type
    Malfunction
    Date Received
    September 12, 2017
    Date of Event
    August 18, 2017
    Report Date
    September 12, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. CONCOMITANT MEDICAL PRODUCTS: FEMTO LASER, SN (B)(4); WAVELIGHT, SN (B)(4). DEVICE MANUFACTURE DATE: UNKNOWN, AS THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. (B)(4). 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 LOSS OF SUCTION IN THE RIGHT EYE (OD) OF A MALE PATIENT AFTER 80% OF FLAP CREATED WITH AN INTRALASE PATIENT INTERFACE (PI) AFTER THE LASER FIRED. THEY REAPPLIED SUCTION AND COMPLETED FLAP CREATION AND SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE LOSS OF BEST CORRECTED VISUAL ACUITY. THERE WAS NO ORAL STEROID PRESCRIBED, NO TOPICAL STEROID DOSAGE WAS INCREASED AND NO FLAP LIFT AND RINSE PERFORMED. THERE WAS NO PROBLEM REPORTED WITH THE PATIENT AND NO SECONDARY SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT HAD NO COMMENTS OR COMPLAINT. BEST CORRECTED VISUAL ACUITY (BCVA) IN RIGHT EYE (OD): (PRE-OP 20/25). BEST CORRECTED VISUAL ACUITY (BCVA) IN LEFT EYE (OS): (PRE-OP 20/20). PRE-OPERATIVE REFRACTION: RIGHT EYE (OD) WAS 20/25 -6.25 X -.50 X 5. LEFT EYE (OS) WAS 20/20 -5.50 X -1.50 X 83.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639591 INTRALASE PATIENT INTERFACE HNO ABBOTT MEDICAL OPTICS PI-RET UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR