BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3233091 · Received July 18, 2013

    Report

    Report Number
    3006695864-2013-00276
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BANDAGE CONTACT LENS (BCL) WAS NOT PLACED AFTER THE INITIAL PROCEDURE. DATE OF BIRTH: (B)(6) 1980. DATE OF PHOTOREFRACTIVE KERATECTOMY (PRK) WAS ON (B)(6) 2013. BCVA (BEST CORRECTED VISUAL ACUITY WITH THAT EYE) PRE-OP WAS 20/20+. UNCORRECTED VISUAL ACUITY (UCVA) WAS 20/40 ON (B)(6) 2013. BCL VISUAL ACUITY (VA) WAS 20/40- ON (B)(6) 2013. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). AC POWER ERROR DURING THUNDERSTORM; FIELD SERVICE ENGINEER (FSE) VERIFIED ERROR IN ERROR LOG. FSE REPLACED UNINTERRUPTED POWER SUPPLY (UPS) AND ALTERNATING CURRENT/DIRECT CURRENT (AC/DC) CONTROL PRINTED CIRCUIT BOARD (PCB) AS A PRECAUTION. REPORT OF VGB AFTER ERROR. FSE WATCHED PATIENT VIDEO, IT APPEARED THERE WAS NO ACTUAL BREAKTHROUGH OF THE VERTICAL GAS RATHER FIVE PRESSURE BUBBLES THAT THE GAS DIDN'T BREAKTHROUGH. FSE VERIFIED THE LASER. ALL APPEARED NORMAL AND WITHIN SPECIFICATION. SYSTEM MEETS AMO SPECIFICATIONS. AMO'S MEDICAL MONITOR, REVIEWED THE PATIENT VIDEO. MEDICAL MONITOR FOUND MULTIPLE AREAS OF VERTICAL GAS BREAKTHROUGH IN SEVERAL LINEAR LOCATIONS IN THE AREA OF THE PREVIOUS LASER PASS AND IN THE PART OF THE CORNEA WHERE THERE WAS NO PREVIOUS LASER PASS. PATIENT HAD NO PRE OP EVIDENCE OF ANY BASEMENT MEMBRANE DYSTROPHY IN EITHER EYE AND NO HISTORY OF TRAUMA OR PTERYGIUM OR RIGID GAS PERMEABLE (RGP) WEAR. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DATE OF THIS REPORT - (B)(6) 2013. DATE RECEIVED BY MANUFACTURER - (B)(4) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    ON (B)(6) 2013, AMO'S FIELD SERVICE ENGINEER (FSE) REPORTED A CASE OF VERTICAL GAS BREAKTHROUGH (VGB) ON PATIENT'S LEFT EYE DURING AN INTRALASE PROCEDURE ON (B)(6) 2013. SUITE EXPERIENCED A POWER SURGE DURING PROCEDURE. AS A CONSEQUENCE OF AN ALTERNATING CURRENT (AC) POWER ERROR ON THE INTRALASE, CUSTOMER POWERED DOWN AND REBOOTED THE SYSTEM. USING THE SAME CONE, SURGEON NOTICED A VGB DURING THIS SECOND ATTEMPT. SURGEON DIDN'T LIFT THE FLAP. ADDITIONAL FOLLOW UP WAS OBTAINED. PHYSICIAN REPORTED THAT THE PATIENT RETURNED WITH SOME INFLAMMATION. PATIENT HAD A LITTLE HEME UNDER THE POCKET FROM NEOVASC WHICH IS RESOLVING. PHYSICIAN HAD STARTED THE PATIENT ON PREDFORTE BECAUSE PHYSICIAN WOULD LIKE THE INTERFACE HAZE TO RESOLVE BEFORE PHOTOREFRACTIVE KERATECTOMY. PHYSICIAN WILL USE MITOMYCIN AT THE TIME. PHYSICIAN WAS UNABLE TO DETECT ANY LATENT EBM IN EITHER EYE. WHEN PHYSICIAN RE-OPERATES, PHYSICIAN WILL START WITH A FLAP IN THE OTHER EYE AND PATIENT MAY GET THE SAME THING AS PHYSICIAN HAD NO EXPLANATION FOR WHY THIS HAPPENED OUTSIDE THE FIRST PASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334913 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other