BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3914876 · Received July 4, 2014

    Report

    Report Number
    3006695864-2014-00320
    Event Type
    Injury
    Date Received
    July 4, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 7, 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

    (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.

    Additional Manufacturer Narrative · 1

    PLACEHOLDER.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED WITH STRIAE IN RIGHT EYE ONE DAY POST TREATMENT. IT WAS STATED THAT THE PATIENT HAD LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT COMPLAINED OF FOREIGN BODY SENSATION IN RIGHT EYE AND POOR NEAR VISUAL ACUITY IN RIGHT EYE. FLAP WAS RE-LIFTED UNDER VISX AT 1 DAY POST TREATMENT AND A BANDAGE CONTACT LENS (BCL)WAS PLACED. BCVA RIGHT EYE PRE-OP 20/15 POST-OP 20/40. BCVA LEFT EYE PRE-OP 20/15 POST-OP NOT REPORTED BY ACCOUNT.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED WITH FOLD/WRINKLES IN RIGHT EYE AT ONE DAY POST TREATMENT. IT WAS STATED THAT THE PATIENT EXPERIENCED LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). PATIENT COMPLAINED OF FOREIGN BODY SENSATION AND POOR NEAR VISION IN RIGHT EYE. BCVA RIGHT EYE PRE-OP 20/15 POST-OP 20/40; BCVA LEFT EYE PRE-OP 20/15 POST-OP NOT REPORTED BY ACCOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392801 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention WAVELIGHT (B)(4)