BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3709747 · Received March 28, 2014

    Report

    Report Number
    3006695864-2014-00171
    Event Type
    Injury
    Date Received
    March 28, 2014
    Date of Event
    February 25, 2014
    Report Date
    February 28, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACRONYM PEK WAS INCORRECTLY IDENTIFIED IN THE INITIAL MDR REPORT. THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED WITH STAGE 2+ PUNCTUATE EPITHELIAL KERATITIS (PEK) CENTRALLY AND ACROSS FLAP IN THE RIGHT EYE APPROXIMATELY TWO WEEKS POST TREATMENT. DEVICE AVAILABLE FOR EVALUATION: YES. : ADDITIONAL REPORT SOURCE: USER FACILITY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    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 CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED WITH STAGE 2+ PUNCTATE EPITHELIAL KERATITIS (PEK) CENTRALLY AND ACROSS FLAP IN THE RIGHT EYE APPROXIMATELY TWO WEEKS POST TREATMENT. DRYNESS WAS NOTED IN THE RIGHT EYE. THE PATIENT WAS ADVISED TO INCREASE ARTIFICIAL TEARS USE AND ADD LIQUIGEL EVERY NIGHT. THE PATIENT EXPERIENCED LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA) OF 2 LINES, FROM 20/20 TO 20/30 POST-OPERATIVELY. IN ADDITION, THE PATIENT COMPLAINED THAT THE VISION IN THE RIGHT EYE WAS GREAT INITIALLY POST-OPERATIVELY BUT WAS GETTING BLURRY. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED WITH STAGE 2+ PUNCTUATE EPITHELIAL KERATITIS (PEK) CENTRALLY AND ACROSS FLAP IN THE RIGHT EYE APPROXIMATELY TWO WEEKS POST TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186540 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other WAVELIGHT 1010-3-245