BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS3

    MDR report key: 4363396 · Received December 29, 2014

    Report

    Report Number
    3006695864-2014-00573
    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

    (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:. POST OP FLAP CHECK: VERY SMALL FIBER IN RIGHT EYE AND ABRASION WITH SMALL EPITHELIAL DEFECT IN LEFT EYE (B)(6) 2010: UCVA OD 20/25+2 OS 20/20, BCVA OD 20/20+2 OS 20/20. (B)(6) 2014: UCVA OD 20/40+1 OS 20/20, BCVA OD 20/20-1 OS 20/20-1. MANIFEST REFRACTION OD +1.50 -3.00 X 68 OS PLANO -0.75 X 107. PRESENTED WITH POSSIBLE EARLY CORNEAL WEAKENING (ECTASIA). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    PATIENT VISUAL ACUITY HISTORY IS AS FOLLOWS'' AND SHOULD HAVE BEEN ''H10'' NOT ''H11''. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DESCRIPTION EVENT IN INITIAL REPORT HAS BEEN CORRECTED TO REFLECT: INTRAOPERATIVE PACHS TO BED: (B)(4). 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) RIGHT EYE (OD) -4 -0.75 X 090 20/20 LEFT EYE (OS) -4.25 -0.50 X 095 20/20. PACHYMETER (PACH) 508 OD, 510 OS. FLAPS INTRALASE 110UM SETTING. INTRAOPERATIVE PACHS TO BED 404 OD, 412 OS. ABLATION DEPTH WAS 69UM OD, 64UM OS. ESTIMATED RESIDUAL STROMAL BED 337UM OD, 348 UM OS. CURRENT STATUS: VISUAL ACUITY SANS CORRECTION (VASC) 20/40 OD, 20/20 OS. RXM OD +1.00 -3.00 X 068 20/20-1, LEFT EYE PLANO -0.75 X 107 20/20-1 PATIENT REFERRED FOR CONTACT LENS FITTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853856 INTRALASE FS3 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20004

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other