BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3901423 · Received June 30, 2014

    Report

    Report Number
    3006695864-2014-00317
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    January 15, 2014
    Report Date
    February 17, 2014
    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

    ACCOUNT REPORTED ON (B)(6) 2014 THAT PATIENT IS STILL EXPERIENCING DRYNESS POST TREATMENT IN BOTH EYES EVEN THOUGH TREATMENT WAS ONLY ON LEFT EYE. PATIENT IS ON OMEGA-3''S, RESTASIS, AN ARTIFICIAL TEAR IN BOTH EYES. THERE IS NO LOSS OF BEST CORRECTED VISUAL ACUITY REPORTED BUT PATIENT REPORTED IS USING A LOT OF DROPS AND VISION FLUCTUATES. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CLINIC IS REPORTING THIS ADVERSE EVENT ONLY AND DID NOT REQUEST OR REQUIRE FIELD SERVICE OR CLINICAL SUPPORT. SURGEON REPORTED THAT SOME OF THE VISION FLUCTUATION MAY BE CAUSED BY THE DRY EYES, HOWEVER, THE DOCTOR DOES NOT FEEL THIS IS THE ONLY CAUSE. PATIENT HAS HAD DIFFICULTIES ADJUSTING TO MONOVISION AND AFTER SEVERAL CONVERSATIONS PRIOR AND AFTER SURGERY DOES NOT UNDERSTAND WHY HER READING EYE IS BLURRY FOR DISTANCE. IN THE END, THE DOCTOR FEELS THERE IS MORE THAN ONE CAUSE TO HER VISION FLUCTUATION ONE COULD BE DUE TO DRY EYES WHICH WILL BE MEASURED AT THE NEXT VISIT (B)(6); HOWEVER, HE ALSO FEELS HER ABILITY TO ADAPT TO MONOVISION IS ALSO A FACTOR. A FOLLOW UP WITH THE ACCOUNT WAS DONE FOR INFORMATION ON THE PATIENT AS SHE WAS GOING TO BE SEEN ON (B)(6) AND THEY REPORTED THAT THERE ARE VERY LITTLE CHANGES SINCE THE PATIENT'S LAST VISIT. PATIENT DECLINED TESTING FOR DRY EYES TO SEE IF THERE IS ANY PROGRESSION OR RESOLUTION. A DISCUSSION ABOUT TREATING THE RIGHT EYE FOR BETTER DISTANCE VISION WAS DONE AND SHOWN TO THE PATIENT AND SHE DEFERRED ANY FURTHER TREATMENT AT THIS TIME. SAME REGIMEN AS LAST VISIT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED WITH DRY EYE IN BOTH EYES 5 MONTHS POST TREATMENT ((B)(6) 2013). IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT COMPLAINED OF VISION FLUCTUATION AND EYES FEELING DRY. IT WAS REPORTED ON (B)(6) 2014 THAT PATIENT¿S DRY EYES IS BEING TREATED WITH A COMBINATION OF MEDICATIONS AND LID HYGIENE. PATIENT IS ON ARTIFICIAL TEARS 4-6 TIMES A DAY, RESTASIS TWICE A DAY, TAKING OMEGA-3'S AND WARM COMPRESSES WITH LID MASSAGE TWICE A DAY. PATIENT REPORTED DIFFICULTY TO SEE AT WORK AND THAT THE VISION FLUCTUATIONS HAS NOT RESOLVED; ALL DURING THE (B)(6) 2014 EXAM. PATIENT IS SCHEDULED FOR ANOTHER FOLLOW UP VISIT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380591 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other WAVELIGHT 1010-3-244