BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS3

    MDR report key: 4361978 · Received December 24, 2014

    Report

    Report Number
    3006695864-2014-00564
    Event Type
    Injury
    Date Received
    December 24, 2014
    Date of Event
    December 2, 2014
    Report Date
    December 2, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SURGERY OCCURRED IN 2010 AND AMO WAS NOTIFIED OF THE EVENTS ON (B)(4) 2014 MAKING IMPOSSIBLE TO OBTAIN INFORMATION ABOUT THE SYSTEM DURING THE TIME OF THE SURGERY. PATIENT VISUAL ACUITY HISTORY IS AS FOLLOWS: PRE EXAMINATION RECORDS FOR PATIENT ATTACHED. PRE-OP MANIFEST OD -7.25 X -0.25 105 BCVA 20/20. PRE-OP MANIFEST OS -6.00 X -0.75 107 BCVA 20/20+. SURGERY DATE (B)(6) 2010. (B)(6) 2010: 1 DAY POST OP, UCVA OD 20/20-1 OS 20/25-2, FOREIGN BODY SENSATION. (B)(6) 2010: UCVA OD 20/30-1 OS 20/25+2, MANIFEST REFRACTION OD +0.50 -0.50 X 14 OS +0.75 -.25 X 120. BCVA OS 20/20. DRYNESS IN AND GLARE IN BOTH EYES. +2 DENSE SUPERFICIAL PUNCTATE KERATITIS (SPK) NOTED IN LOWER AREA OF FLAP (AROUND 6 O¿CLOCK) NOTED IN LEFT EYE. PREDFORTED TEARS GIVEN. (B)(6) 2010: UCVA OD 20/20-1 OS 20/20, MANIFEST REFRACTION OD +1.00 -0.50 X 25 OS +1.00 -.25 X 105. BCVA OD 20/20-1 OS 20/20. NO MENTION OF DRY EYE OR SPK. STILL USING ARTIFICIAL TEARS. (B)(6) 2010: UCVA OD 20/20-2 OS 20/20-1, MANIFEST REFRACTION OD +0.50 -0.25 X 30 OS +1.00 -.50 X 105. BCVA OD 20/20 OS 20/20. PATIENT CONSIDERING PUNCTUAL PLUGS IF DRYNESS AND SPK CONTINUES (TRACE IN RIGHT EYE AND IN TWO AREAS OF LEFT EYE). STILL USING ARTIFICIAL TEARS. DRY EYES AT TIMES. (B)(6) 2010: UCVA OD 20/20 OS 20/25+1, MANIFEST REFRACTION OD +0.25 -0.25 X 25 OS +0.75 -0.75 X 92. DIFFUSE SPK NOTED IN LEFT EYE ONLY. STILL ON ARTIFICIAL TEARS. DRY EYES AT TIMES. BCVA OD 20/20 OS 20/2. (B)(6) 2011: UCVA OD 20/20 OS 20/25-2, MANIFEST REFRACTION OD -0.25 -0.25 X15 OS +0.75 -0.75 X 90. DRY EYE FREQUENT IN BOTH EYES. STILL ON ARTIFICIAL TEARS. BCVA OD 20/20 OS 20/20-1. (B)(6) 2013: UCVA OD 20/30 OS 20/60, MANIFEST REFRACTION OD +1.25 -0.75 X 25 OS +0.25 -2.25 X 125. PATIENT COMPLAINT OF DRY EYE SYNDROME IN LEFT EYE MORE THAN RIGHT EYE. LEFT EYE WAS INITIALLY BETTER BUT EYES DID NOT WORK WELL TOGETHER. NOW LEFT HAS MONO DIPLOPIA WORST WITH TIME. STILL ON ARTIFICIAL TEARS. SPK IN LEFT EYE. BCVA OD 20/15-2 OS 20/30+. (B)(6) 2013: UCVA OD 20/30 OS 20/60, MANIFEST REFRACTION OD +1.25 -0.75 X 25 OS +0.25 -2.25 X 125. SPK IN LEFT EYE. BCVA OD 20/20 OS 20/30+. (B)(6) 2013: MANIFEST REFRACTION OD +1.25 -0.75 X 30 OS +1.00 -3.25 X 130, INTRAOCULAR PRESSURE IN RIGHT 13MMHG AND IN LEFT 10MMHG. BCVA OD 20/20-1 OS 20/30-1. (B)(6) 2013: MANIFEST REFRACTION OD +0.25 OS -3.00 -0.50 X 30, INTRAOCULAR PRESSURE IN RIGHT 14MMHG AND IN LEFT 12MMHG. BLEPHARITIS IN BOTH EYES BCVA OD 20/20 OS 20/30. (B)(6) 2013: UCVA OD 20/30 OS 20/60-1. MANIFEST REFRACTION OD -0.25 OS -3.00 -0.50 X 25. INTRAOCULAR PRESSURE IN RIGHT 14MMHG AND IN LEFT 11MMHG. BCVA OD 20/20 OS 20/30-3. (B)(6) 2014: UCVA OD 20/20 OS 20/60-1, MANIFEST REFRACTION OD -0.25 -0.25 X 55 OS -2.50 -0.+0.75 X 155. INTRAOCULAR PRESSURE IN RIGHT 14MMHG AND IN LEFT 10MMHG. BCVA OD 20/15-1 OS 20/30-2. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT HAD LASIK SURGERY ON (B)(6) 2010. ACCOUNT REPORTED ON (B)(6) 2014 THAT PATIENT PRESENTED WITH CORNEAL ECTASIA. PETACAMS WITHIN NORMAL LIMITS (WNL). PRESCRIPTION (RXM) OD -7.00 -.25 X 129 20/20, LEFT EYE (OS) -6.25 -0.75 X 120 20/20. PACHYMETER (PACH) 530 OD, 527 OS. FLAPS INTRALASE 110UM SETTING. INTRAOPERATIVE PACHS TO BED 424 OD, 423 OS. ABLATION DEPTH WAS 110UM OD, 103UM OS. ESTIMATED RESIDUAL STROMAL BED 314UM OD, 310 UM OS. CURRENT STATUS: VISUAL ACUITY SANS CORRECTION (VASC) 20/20 OD, 20/400 OS. RXM OD +.025 20/20, OS -3.50 -0.50 X 030 20/30. PATIENT REFERRED FOR CONTACT LENS FITTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849559 INTRALASE FS3 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20004

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other