BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR

    MDR report key: 5346017 · Received January 5, 2016

    Report

    Report Number
    3006695864-2016-00008
    Event Type
    Injury
    Date Received
    January 5, 2016
    Date of Event
    June 25, 2015
    Report Date
    January 5, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION PROVIDED BY THE MANUFACTURER 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.

    Description of Event or Problem · 1

    THE SURGERY CENTER REPORTED A LASER TREATMENT PATIENT EXPERIENCED AN ANTERIOR HAZE ON BOTH EYES (OU) AT A 1 WEEK POST OP EXAM. A BRIEF DESCRIPTION OF THE EVENT WAS THAT BY ONE WEEK POST OP, BOTH EYES WERE RE-EPITHELIZED BUT THE VISUAL ACUITY (VA) WAS STILL BLURRY. AT ONE WEEK POST OP, THE VISUAL ACUITY WITHOUT CORRECTION (VASC) WAS 20/30 ON RIGHT EYE (OD) GREATER THAN THE LEFT EYE (OS). THE PATIENT WAS ADVISED TO CONTINUE THE STEROID DROPS (GTTS) AND INCREASE EVERY 2 HOURS (Q2H) FOR ONE WEEK AND TO DISCONTINUE (D/C) THE ANTIBIOTIC. THE PATIENT WAS SEEN WEEKLY AND THE FLUOROMETHOLONE OPHTHALMIC SUSPENSION (FML - TOPICAL ANTI-INFLAMMATORY PRODUCT) WAS TO BE TAPERED TO THREE TIMES A DAY (TID) AT ONE MONTH TO TWICE DAY (BID) AT TWO MONTHS. AT 3 MONTH POST OP EXAM, THE HAZE HAD WORSEN, THEREFORE, THE FML WAS INCREASED TO FOUR TIMES A DAY (QID) FOR OU. THE VISUAL ACUITY WITH CORRECTION (VACC) CONTINUED TO BE 20/20. AT 4 MONTH POST OP, EXAM THE VASC FOR OU WAS 20/20. AT 6 MONTH POST OP EXAM, THE INTRAOCULAR PRESSURE (IOP) WAS AT 14.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4386 STAR EXCIMER LASER LZS ABBOTT MEDICAL OPTICS 0030-1479

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention