BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3780935 · Received April 30, 2014

    Report

    Report Number
    3006695864-2014-00254
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    January 14, 2014
    Report Date
    April 17, 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

    ADDITIONAL INFORMATION: ACCOUNT REPORTED THAT PATIENT WAS SEEN ON (B)(6) 2015. DRY EYES IS BETTER BUT DOES FLUCTUATE. HAS NOT DONE RESTASIS AS RECOMMENDED IN A COUPLE OF WEEKS. PATIENT IS BCVA 20/25+1 RIGHT AND 20/30+1 LEFT. PATIENT WAS SEEN BY OPTOMETRIST AND WAS DIAGNOSED WITH CATARACTS IN LEFT EYE MORE THAN IN RIGHT EYE. PATIENT'S DRY EYE IS IMPROVING IN BOTH EYES WITHOUT RESTASIS AND SHE HAS BEEN ADVISED TO CONTINUE ARTIFICIAL TEARS AND FRESH KOTE.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED WITH DRY EYE AND BEST CORRECTED VISUAL ACUITY (BCVA) DECREASED IN BOTH EYES ONE MONTH POST TREATMENT. THE PATIENT STATED VISION FLUX WITH DRYNESS AND COMPLAINED THAT VISUAL ACUITY IS BETTER IN THE MORNINGS AND BY EVENING IS GONE. RIGHT EYE BCVA PRE OP 20/15 POST OP 20/40; LEFT EYE BCVA PRE OP 20/15 POST OP 20/30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260403 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other WAVELIGHT (B)(4)