BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 4037736 · Received August 26, 2014

    Report

    Report Number
    3006695864-2014-00402
    Event Type
    Injury
    Date Received
    August 26, 2014
    Date of Event
    July 31, 2014
    Report Date
    August 6, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EPITHELIAL INGROWTH AND IRRIGATION REQUIRED. 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

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED WITH EPITHELIAL INGROWTHS IN BOTH EYES AT 2 WEEK POST-OPERATIVE EXAM. THE PATIENT¿S EYES REQUIRED IRRIGATION AND TOPICAL STEROID DOSAGE WAS INCREASED. IN ADDITION, A FLAP AND RINSE WAS PERFORMED. THE PATIENT COMPLAINED OF BLURRY NEAR AND FAR VISION. THE PATIENT DID NOT EXPERIENCED LOSS OF BEST CORRECTED VISUAL ACUITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516245 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention VISX SN# (B)(4)