BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 4182550 · Received October 17, 2014

    Report

    Report Number
    3006695864-2014-00459
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 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

    ADDITIONAL INFORMATION WAS RECEIVED FROM SURGERY CENTER AND IS PROVIDED IN DESCRIPTION OF EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    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. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THIS TIME HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT CHIEF COMPLAINT WAS BOTH EYES HAVE BLURRY VISION AND DRY EYE AT 1 WEEK POST OP EXAM. THE SURGERY CENTER REPORTED THE PATIENT HAD A LOSS OF BEST CORRECTED VISUAL ACUITY. THE CLINIC REPORTED RIGHT EYE(OD) BEST CORRECTED VISUAL ACUITY (BCVA) DISTANCE 20/25 (PRE-OP 20/15) AND AND LEFT EYE (OS) BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/30 (PRE-OP 20/15). THE PATIENT¿S COMMENT WAS THAT PATIENT CONSULTED WITH AN OPHTHALMOLOGIST AND WAS RECOMMENDED PLUGS.

    Description of Event or Problem · 1

    THE ACCOUNT PROVIDED ADDITIONAL INFORMATION AS TO PATIENT'S DRYNESS HAS NOT RESOLVED BUT IMPROVING. NO SECONDARY SURGERY IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661239 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other WAVELIGHT SERIAL NO. (B)(4)