BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3438565 · Received October 30, 2013

    Report

    Report Number
    3006695864-2013-00388
    Event Type
    Injury
    Date Received
    October 30, 2013
    Date of Event
    August 8, 2013
    Report Date
    October 3, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CLINIC IS REPORTING THIS ADVERSE EVENT ONLY AND DOES NOT REQUEST OR REQUIRE FIELD SERVICE OR CLINICAL SUPPORT. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTION SHOULD BE K060372. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE CLINIC DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT AT THE TIME OF THIS REPORT HOWEVER CLINICAL SUPPORT WAS REQUESTED APPROXIMATELY 10 WEEKS AFTER THE REPORT DUE TO CONCERNS WITH TLSS. PATIENT DATA WAS COLLECTED AND RECOMMENDATIONS ON MEDICATION WAS PROVIDED.ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED WITH TLSS (TRANSIENT LIGHT SENSITIVITY SYNDROME) AT THE 3 MONTH POST OP VISIT. THE PATIENT WAS PRESCRIBED PRED FORTE DROPS FOUR TIMES A DAY AND IS REPORTED AS IMPROVING. THE PATIENT'S VISUAL ACUITY WAS 20/20 IN THE RIGHT EYE AND 20/15 IN THE LEFT EYE. THE CONDITION IS IMPROVING; HOWEVER, HAS NOT YET RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557393 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other