BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 4805685 · Received May 29, 2015

    Report

    Report Number
    3006695864-2015-00238
    Event Type
    Injury
    Date Received
    May 29, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 1, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).: THE CLINIC IS REPORTING THIS ADVERSE EVENT ONLY AND DID NOT REQUEST OR REQUIRE FIELD SERVICE OR CLINICAL SUPPORT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT EXPERIENCED ECTASIA ON BOTH EYES (OU) AT 6 YEAR POST OP EXAM. THE SURGERY CENTER¿S BRIEF DESCRIPTION WAS THAT THE PATIENT HAS EARLY ECTASIA. THE PATIENT¿S CHIEF COMPLAINT WAS BLURRY VISION. SECONDARY SURGICAL INTERVENTION WAS REQUIRED CUSTOM ABLATION TREATMENT/CROSS-LINKING( TCAT/CAT). PRE-OPERATIVE MEASUREMENTS DATE: (B)(6) 2009: BCVA 20/20 OD, 20/20 OS, SPHERE -2.215 OD, -2.25 OS, CYLINDER 0 OD, -.25 OS, AXIS 0 OD, 0 OS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350812 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention WAVELIGHT SERIAL NO. (B)(4)