BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3964188 · Received July 29, 2014

    Report

    Report Number
    3006695864-2014-00362
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    January 4, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    IN INITIAL REPORT, ADDITIONAL INFORMATION WAS NOT PROVIDED AS IT SHOULD ALSO HAVE INCLUDED THE FOLLOWING: TRACE ABRASION RIGHT CORNEAL FLAP SUPERIORLY. SEEING 20/25 BOTH EYES. SPK OU ON 2ND DAY, TOBRADEX FOR CORNEAL EDEMA AND HAZE THEN LOTEMAX AND DURAZOL. (B)(4). 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 ABRASION, DRY EYE AND BLURRY VISION IN RIGHT EYE ONE DAY POST TREATMENT. THE TOPICAL STEROID DOSAGE WAS INCREASED AND FLAP LIFT AND RINSE WAS DONE. IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT COMPLAINED OF DRY EYES AND BLURRY VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442481 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention WAVELIGHT 1010-3-247