BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3092684 · Received May 3, 2013

    Report

    Report Number
    3006695864-2013-00152
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 9, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: THE EQUIPMENT WAS EVALUATED AFTER THE TREATMENT DATE. AN ABBOTT MEDICAL OPTICS (AMO) FIELD SERVICE ENGINEER (FSE) WAS ONSITE TO EVALUATE THE SYSTEM. THE FSE WAS NOT ABLE TO DETERMINE THE CAUSE OF THE EVENT. ALL PARAMETERS MEET AMO SPECIFICATIONS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, DLK COMPLETELY RESOLVED WITH STEROID TREATMENT. UNCORRECTED VISUAL ACUITY (UCVA) AND BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/25 ON BOTH EYES. SURGEON ATTRIBUTES 20/25 ACUITY TO DRYNESS AND EARLY POST OP PERIOD OF HYPEROPIC TREATMENT.

    Description of Event or Problem · 1

    PATIENT DEVELOPED DENSE DIFFUSE LAMELLAR KERATITIS (DLK) ON BOTH EYES BY POST-OP DAY #1. DURING PATIENT'S INTRALASE PROCEDURE, THERE WAS MUCH MORE OPAQUE BUBBLE LAYER OBL ON BOTH EYES THAN NORMAL, AND DOCTOR HAD TO SCRAPE IT OUT PRIOR TO TREATMENT. DOCTOR PERFORMED A FLAP LIFT AND IRRIGATION, ALONG WITH CULTURES, BOTH EYES ON POST OP DAY #1. IT LOOKED MUCH BETTER ON POST OP DAY #2, BUT THERE WAS STILL SOME DLK IN THE SAME LOCATION BOTH EYES. PATIENT IS NOW ON PRED FORTE HOURLY. ALSO, THE CULTURES CAME BACK NEGATIVE. PRE-OP BEST CORRECTED VISUAL ACUITY WAS 20/20 BOTH EYES. POST-OP BCVA AT THE DAY # 1 (AFTER FLAP LIFT), 20/40 RIGHT EYE AND 20/20 LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193659 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other| R