BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS3

    MDR report key: 4366967 · Received December 29, 2014

    Report

    Report Number
    3006695864-2014-00574
    Event Type
    Injury
    Date Received
    December 29, 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

    THE FOLLOWING PATIENT HISTORY INFORMATION WAS NOT INCLUDED IN THE INITIAL REPORT: POST OP FLAP CHECK: VERY SMALL FIBER IN RIGHT EYE AND ABRASION WITH SMALL EPITHELIAL DEFECT IN LEFT EYE. ON (B)(6)-2010: UCVA OD 20/25-2 WITH GLARE OS 20/20+3, MANIFEST REFRACTION OD +.50 OS +.75 -, BCVA OD 20/15-1 OS 20/20+3, PATIENT GIVEN LUBRICANT DROPS. ON (B)(6)-2010: UCVA OD 20/20+1 OS 20/20, BCVA OD 20/20+ OS 20/20+, MANIFEST REFRACTION OD +.50 OS +.50, PATIENT COMPLAINT OF DRY EYE AND HEADACHES. ADVISED NIGHT LUBRICATION AND (B)(4). ON (B)(6)-2010: UCVA OD 20/20+ OS 20/20+, BCVA OD 20/20+ OS 20/20+, MANIFEST REFRACTION OD +.75 OS +.75, PATIENT COMPLAINT OF LIGHT SENSITIVITY AND HEADACHES. PATIENT SHOWS SOME RESIDUAL HYPEROPIA. PATIENT USING REFRESH AND RESTASIS. ON (B)(6)-2010: UCVA OD 20/20 OS 20/20, BCVA OD 20/20, MANIFEST REFRACTION OD +.75 OS +.75, PATIENT COMPLAINT OF LIGHT SENSITIVITY (PHOTOPHOBIA) AND CHRONIC HEADACHES. ON (B)(6)-2010: UCVA OD 20/20-1 OS 20/20+3, BCVA OD 20/15 OS 20/15, MANIFEST REFRACTION OD +.75 OS +.75 SPHERE, PATIENT COMPLAINT OF LIGHT SENSITIVITY AND HEADACHES. PATIENT HAD SOME SUPERFICIAL, PUNCTATE KERATITIS, DIFFUSE LAMELLAR KERATITIS (DLK) AND HAZE IN BOTH EYES. PATIENT USING ARTIFICIAL TEARS. ON (B)(6)-2010: UCVA OD 20/20 OS 20/25+1, BCVA OD 20/20 OS 20/20, MANIFEST REFRACTION OD +.75 -0.25 X 15 OS +.75 -0.50 X 176, PATIENT COMPLAINT OF SHARP PAIN IN THE FOREHEAD REGION, DULL PAIN DAILY AND CONSTANT WITH NO RELIEF FROM (B)(4), PATIENT HAD SOME SUPERFICIAL PUNCTATE KERATITIS. PATIENT USING ARTIFICIAL TEARS. PATIENT WEARS SPECTACLES (B)(6) OF TIME AND NO HEADACHES ARE REPORTED WHEN USING THEM. ON (B)(6)-2011: UCVA OD 20/15-1 OS 20/15-2, BCVA OD 20/15-1 OS 20/15, MANIFEST REFRACTION OD +.50 -0.25 X 172 OS +1.50 -0.25 X 165. PATIENT HAD BOTOX INJECTIONS FOR THE HEADACHES 4 MONTHS AGO AND MENTIONED IT HELPS. SIGHT IS PERFECT. PATIENT SAW NEURO-OPHTHALMOLOGIST 2 DAYS AGO AND EVERYTHING WAS PERFECT. PATIENT HAD SOME SUPERFICIAL PUNCTATE KERATITIS. PER NEUROLOGY OPHTHALMOLOGY REPORT PATIENT IS ALSO TAKING FINASTERIDE AND CLONAZEPAM AND HE HAD A FAINTING EPISODE DURING THE BOTOX INJECTION (PATIENT HAS PRE-EXISTING CONDITION OF VASOVAGAL EPISODES). ON (B)(6)-2011: UCVA OD 20/20 OS 20/20, BCVA OD 20/20 OS 20/20, MANIFEST REFRACTION OD +1.25 -0.25 X 172 OS +1.50 -0.25 X 015. ON (B)(6)-2013: UCVA OD 20/20 J1 AT NEAR AND OS 20/30 J1 AT NEAR, MANIFEST REFRACTION OD PLANO OS +0.25 +0.75 X 65 20/20+1, PATIENT CURRENT MEDICATIONS ARE CLONAZEPAM, PROPANOLOL, FENESTERIDE AND BOTOX INJECTIONS AND THE ARTIFICIAL TEARS . HE COMPLAINTS OF BLURRED VISION IN THE LEFT EYE AND HE DESCRIBES A HALO AROUND OBJECTS ESPECIALLY WHITE OBJECTS. HE STILL EXPERIENCED CHRONIC HEADACHES AND DRY EYES. INTRAOCULAR PRESSURE IS 10MMHG FOR BOTH EYES. EYESYS TOPOGRAPHY STUDY SHOWS IRREGULAR ASTIGMATISM GREATER IN HIS LEFT EYE AND POSSIBLE ECTASIA OF THE LEFT EYE. ON (B)(6)-2014: UCVA OD 20/20 OS 20/80, MANIFEST REFRACTION OD PLANO WITH BCVA 20/20 AND OS +1.25 +1.00 X30 BCVA 20/25. PATIENT PRESENTED WITH MODERATE DRY EYE AND SEVERE HEADACHES. POST LASIK HYPEROPIA IN LEFT EYE WITH IRREGULAR TOPOGRAPHY IN LEFT EYE. DISCUSSED WITH PATIENT THAT HEADACHES ARE NOT RELATED TO EYE PROBLEMS AND DRY EYE TREATMENTS.

    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:. (B)(6) 2010: PRE OP OD: 20/300, OS: 20/300. (B)(6) 2010: VISUAL ACUITY IS PERFECT BUT SOMETIMES HAS SEVERE HEADACHES AND USES REFRESH AND RESTASIS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. 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 - 2.75- 1.00 X 084 20/20, LEFT EYE (OS) - 2.25 - 1.25 X 090 20/20. PACHYMETER (PACH) 538 OD, 531 OS. FLAPS INTRALASE 110UM SETTING. INTRAOPERATIVE PACHS TO BED 431 OD, 434 OS. THE ABLATION DEPTH WAS 74UM OD, 68UM OS. ESTIMATED RESIDUAL STROMAL BED 357UM OD, 366UM OS. CURRENT STATUS: VISUAL ACUITY SANS CORRECTION (VASC) 20/20- OD, 20/80 OS. RXM OD PLANO 20/20 -1, OS +1.00 +1.00 X 30 20/25. PATIENT REFERRED FOR CONTACT LENS (CL) FITTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853421 INTRALASE FS3 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20004

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other RESTASIS, BOTOX, PROPECIA, PROTRIPTYLINE