BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 4796833 · Received May 26, 2015

    Report

    Report Number
    3006695864-2015-00229
    Event Type
    Injury
    Date Received
    May 26, 2015
    Date of Event
    April 27, 2015
    Report Date
    April 27, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REQUIRED INTERVENTION HAS BEEN ADDED FOR OUTCOMES ATTRIBUTED TO ADVERSE EVENT DUE TO THE FOLLOW UP INFORMATION RECEIVED. INFORMATION WAS RECEIVED ON PATIENT UPDATE CONDITION: LIGHT SENSITIVITY HAS BEEN RESOLVED WITH THERAPY WITHIN 8 WEEK POST OP EXAM. THE PATIENT HAS BEEN ASKED TO USE MORE VISCOUS ARTIFICIAL TEARS AND OINTMENTS. (REFRESH CELLUVIC AND REFRESH PM). IN ADDITION, THE PATIENT IS TAKING A DIETARY SUPPLEMENT CALLED HYDROEYE. THE SURGEON IS STARTING THE PATIENT ON RESTASIS AS THE DRYNESS/SPK IS STILL AN ISSUE. ON (B)(6) 2015, LIGHT SENSITIVITY WAS RESOLVED. 3 + DIFFUSE SUPERFICIAL PUNCTATE KERATITIS (SPK) ON RIGHT EYE AND 2 + DIFFUSE SUPERFICIAL PUNCTATE KERATITIS (SPK). VISUAL ACUITY (VA) ON RIGHT EYE (OD) 20/70, LEFT EYE (OS) 20/40. TREATMENT PLAN WAS LOTEMAX GEL AND USE OF CELLUVIC 6 OR MORE TIMES A DAY. REFRESH PM EVERY BED TIME (QHS). CONTINUE HYDROEYE TWICE A DAY (BID). ON (B)(6) 2015 PATIENT HAD REPORTED BLURRY DVA. SPK SIGNIFICANTLY IMPROVED SINCE LAST POST OP VISIT. TR DIFFUSE SPK IN BOTH EYES. INSERTED PUNCTAL PLUGS ON BOTH LOWER LIDS. USE LOTEMAX GEL THREE TIMES A DAY AT BED TIME (TID-QID) OU VA ON OD 20/40 OS 20/60. ON (B)(6) 2015, PATIENT HAD REPORTED BLURRY; DISTANCE VISUAL ACUITY (DVA) AND VISUAL ACUITY (VA) 20/40 OD, OS. THE PATIENT HASN¿T BEEN USING ANY EYE DROPS OR SUPPLEMENTS AS RECOMMENDED. EXAM SHOWED DIFFUSE SPK CENTRALLY. PATIENT WAS ASKED TO USE HYDROEYE SUPPLEMENTS BID, CELLUVIC TEARS Q1HR, RESTASIS, BID AND REFRESH PM UNG QHS. ON (B)(6) 2015: THERE WAS MORE DRYNESS ON OD THAN OS. PATIENT IS COMPLAINING OF BLURRED VISION. CONTINUE USE OF RESTASIS BID, TEARS Q1HR AND REFRESH PM UNG. IF DRYNESS IMPROVED, THE PATIENT WILL HAVE ENHANCEMENT TREATMENT FOR BLURRY DVA. (B)(4).

    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. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT DEVELOPED SUPERFICIAL PUNCTATE KERATITIS (SPK) ON BOTH EYES (OU). THE SURGERY CENTER DESCRIBED DIFFUSE SPK ON OU SINCE TREATMENT DAY OF (B)(6) 2015. IN ADDITION, THE PATIENT REPORTED LIGHT SENSITIVITY. THE PATIENT IS TO USE PRESERVATIVE-FREE ARTIFICIAL TEARS (PFATS) EVERY HOUR(Q1H), GEL NIGHTLY (QHS), AND LOTEMAX GEL FOUR TIMES DAILY (QID). THE PATIENT IS TO RETURN IN ONE WEEK. THE PATIENT¿S CHIEF COMPLAINT WAS DRY EYE AND COMMENTED ON DRYNESS, FLUCTUATING VISION AND LIGHT SENSITIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339760 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other WAVELIGHT SERIAL NO. (B)(4)