BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRALASE FS2

    MDR report key: 2494990 · Received March 16, 2012

    Report

    Report Number
    3006695864-2012-00048
    Event Type
    Malfunction
    Date Received
    March 16, 2012
    Date of Event
    February 7, 2012
    Report Date
    June 29, 2012
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: A VISUAL AND FUNCTIONAL INSPECTION WAS DONE ON THE GALVO BLOCK. THERE WAS NO OBVIOUS PHYSICAL DAMAGE TO GALVO BLOCK WAS OBSERVED, HOWEVER, THIS ASSEMBLY FAILED FUNCTIONAL TESTING. THE FAILURE OF THIS ASSEMBLY WAS ATTRIBUTED TO A DEFECTIVE ¿X¿ GALVO DRIVER. A DEFINITIVE CAUSE FOR THE "X" GALVO DRIVER FAILURE COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THIS EVENT MAY BE DUE TO HANDLING. HOWEVER, THERE IS NO INFORMATION INDICATING USER ERROR, MISUSE OR HANDLING DAMAGE. NOTE: ALL PERTINENT INFORMATION AVAILABLE TO AMO AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AN AMO FIELD SERVICE ENGINEER (FSE) VISITED SITE AND EXAMINED THE LASER. FSE PERFORMED A TEST IN GEL TO SCOPE THE SERVICE OF THE CUT QUALITY OF THE FLAP. IN TEST GEL THE FLAP WAS DIFFICULT TO OPEN AT THE SAME LOCATION FROM THE REPORTED EVENT. EXAMINATION OF THE SIDE CUT RETRACE FACTOR AND AN ATTEMPT TO REACH IMPROVEMENT OF THE SIDE CUT BY SETTING OTHER FACTOR VALUES FAILED. FSE REPLACED THE GALVO BLOCK AS THIS WAS THE SUSPECTED CAUSE OF THE FLAP ISSUE. THE REPLACEMENT OF THE GALVO BLOCK LEAD TO THE DESIRED RESULT. THE ADJUSTMENT OF THE SIDE CUT RETRACE FACTOR COULD BE MADE IN A WAY THAT THE CUTS IN SIDE CUT LAID ON TOP OF EACH OTHER EXACTLY. A CHECK OF THE CUT IN TEST GEL CONFIRMED THE SUCCESS. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING A FIELD SERVICE ENGINEER (FSE) VISIT, THE DOCTOR REPORTED THAT DURING THE FLAP LIFT OF A LASIK PROCEDURE THE SIDE CUTS WERE NOT PERFORMED WELL ON THE LEFT EYE AT APPROXIMATELY THE 9 O'CLOCK TO 10 O'CLOCK POSITION. DURING THE LIFT, THE FLAP WAS CUT NEAR THE VISUS AREA (ONE PART OF THE FLAP REMAINED IN THE POSITION WHILE THE OTHER WAS LIFTED. BEST CORRECTED VISUAL ACUITY PRE-OPERATIVE WAS 1.0 BOTH EYES (OU). ONE (1) DAY POST-OPERATIVE UNCORRECTED VISUAL ACUITY WAS 1.0 RIGHT EYE (OD) / 0.80 LEFT EYE (OS). ONE (1) WEEK POST-OPERATIVE UNCORRECTED VISUAL ACUITY WAS 0.80 OD / 0.60 OS. THE DOCTOR INDICATED THAT THE WORSENED SIGHT IS NOT UNUSUAL AFTER 1 WEEK. ONE (1) MONTH POST-OPERATIVE 1.0+2 OD / 1.0-2 OS. THE PATIENT INDICATED HE IS SATISFIED WITH HIS OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE FS2 FEMTOSECOND LASER HNO AMO MANUFACTURING USA, LLC 20003K

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other