BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3762441 · Received April 21, 2014

    Report

    Report Number
    3006695864-2014-00241
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 3, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): (PUNCTATE EROSIVE KERATOPATHY). THE EQUIPMENT WAS NOT EVALUATED AFTER THE TREATMENT BECAUSE THERE WAS NO INDICATION THAT A MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE CLINIC IS REPORTING THIS EVENT ONLY AND DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT PATIENT HAS DIFFUSE 3+ PUNCTATE EROSIVE KERATOPATHY PEK IN THE RIGHT EYE. PATIENT WAS USING LOTS OF NON PRED FORTE FREE ARTIFICIAL TEARS IN THE RIGHT EYE. PATIENT PUT ON RESTASIS AND PRED FORTE ARTIFICIAL TEARS. PATIENT WITH A BLURRY RIGHT EYE AND DRY EYE. AN ORAL STEROID WAS NOT PRESCRIBED. TOPICAL STEROID DOSAGE WAS NOT INCREASED. A FLAP LIFT AND RINSE WAS NOT PERFORMED. PATIENT EXPERIENCED A LOSS OF BEST CORRECTED VISUAL ACUITY. PRE-OP BCVA WAS 20/20 ON BOTH EYES. POST-OP BCVA WAS 20/40 IN THE RIGHT EYE AND 20/20 IN THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240643 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other