BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS3

    MDR report key: 4361907 · Received December 24, 2014

    Report

    Report Number
    3006695864-2014-00563
    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).

    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-OP MANIFEST OD -2.25 X -0.50 172 BCVA 20/15-1. PRE-OP MANIFEST OS -2.00 X -1.00 173 BCVA 20/15. PRESCRIPTION (RXM) OD -2.50 -.50 X 168 20/20, LEFT EYE (OS) -2.00 -0.75 X 177 20/20. PACHYMETER (PACH) 536 OD, 519 OS. FLAPS INTRALASE 110UM SETTING. INTRAOPERATIVE PACHS TO BED 423 OD, 401 OS. ABLATION DEPTH WAS 60UM OD, 57UM OS. ESTIMATED RESIDUAL STROMA BED 363UM OD, 344 UM OS. SURGERY DATE (B)(6) 2010. (B)(6) 2013: 1 WEEK POST OP, UCVA OD 20/15-1 OS 20/20-2. MANIFEST REFRACTION OD +0.25 -.25 X 75 OS +0.75 -.50 X 115. BCVA OU 20/15-1. (B)(6) 2010: UCVA OD 20/15-1 OS 20/30-2, MANIFEST REFRACTION OD PLANO OS +0.75 -.52 X 100. BCVA OD 20/15-1 OS 20/20+2. DRYNESS IN LEFT EYE. (B)(6) 2010: UCVA OD 20/15 OS 20/30-1, MANIFEST REFRACTION OD PLANO OS +1.00 -.75 X 95. BCVA OD 20/15 OS 20/20. OU DRY, OS BLURRY. MEDS FOR LUBRICATION Q1HR. PATIENT NOT HAPPY WITH LEFT EYE VISUAL ACUITY. WILL CONSIDER ENHANCEMENT NEXT APPOINTMENT. (B)(6) 2010: UCVA OD 20/15-2 OS 20/25-2, MANIFEST REFRACTION OD PLANO OS +.75 -.50 X 110. BCVA OD 20/15-1 OS 20/15-2. PATIENT VERY DISTRESSED BY LEFT EYE VISUAL ACUITY. (B)(6) 2010: UCVA OD 20/15 OS 20/20, REFRACTION OD +0.25 SPH OS +0.50 - 0.50 X 096. PATIENT ADVISED THAT ENHANCEMENT NOT AN OPTION AT THIS TIME IN LEFT EYE. MAY CONSIDER SPECS IF HE LIKES. BCVA OD 20/15 OS 20/20. (B)(6) 2011: UCVA OD 20/15 OS 20/20-1, MANIFEST REFRACTION OD PLANO OS +0.75 - .50 X 110. PATIENT ADVISED THAT ENHANCEMENT NOT AN OPTION AT THIS TIME IN LEFT EYE. MAY CONSIDER SPECS IF HE LIKES. BCVA OD 20/15 OS 20/20. (B)(6) 2013: COMPREHENSIVE ANNUAL EXAM, VISION COMPLAINT - LEFT EYE WITHOUT SPECTACLE CORRECTION. ONGOING INTERMITTENT BLUR ESPECIALLY WHEN DRY. REFRACTION OD PLANO -.25 X 005 DVA: 20/20 NVA: 20/20. REFRACTION OS +3.00 -1.75 X 120 DVA: 20/20 NVA: 20/20. BOTH EYES DVA AND NVA 20/20. (B)(6) 2013: UCVA OD 20/20 OS 20/70-1, MANIFEST REFRACTION OD -0.25 OS +1.50 -2.00 X 93. BCVA OD 20/20 OS 20/25. PATIENT PRESENTED WITH BLEPHARITIS IN BOTH EYES. (B)(6) 2013: UCVA OD 20/20 OS 20/70, MANIFEST REFRACTION OD -.25 -.25 X180 OS +3.50 -2.50 X 115. BCVA OD 20/20 OS 20/20. (B)(6) 2013: UCVA OD 20/20- OS 20/70, MANIFEST REFRACTION OD -0.25 -0.25 X 180 OS +1.50 -2.00 X 100. BCVA OD 20/20 OS 20/25. PATIENT PRESENTED WITH BLEPHARITIS IN BOTH EYES. CURRENT STATUS: VISUAL ACUITY SANS CORRECTION (VASC) 20/20 OD, 20/70 OS. RXM OD PLANO 20/20, OS + 3.50 - 2.50 X 115 20/20. PATIENT REFERRED FOR CONTACT LENS FITTING. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    IT WAS MENTIONED THE DATE OF THE ONE WEEK POST OP AS (B)(6) 2013. THE DATE SHOULD BE (B)(6) 2010.

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849558 INTRALASE FS3 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20004

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other