BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR

    MDR report key: 3930294 · Received July 11, 2014

    Report

    Report Number
    3006695864-2014-00329
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    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.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT THAT HAD PRK (PHOTOREFRACTIVE KERATECTOMY) PROCEDURE PRESENTED WITH CORNEAL HAZE IN LEFT EYE 3 MONTHS POST TREATMENT. THE TOPICAL STEROID DOSAGE WAS INCREASED. IT WAS STATED THAT THE PATIENT EXPERIENCED LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT COMPLAINED OF BLURRY VISION IN LEFT EYE AND CAN'T SEE WHEN HE CLOSE HIS RIGHT EYE. BCVA RIGHT EYE PRE-OP 20/25, POST-OP 20/25. BCVA LEFT EYE PRE-OP 20/25, POST-OP 20/40.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406298 STAR EXCIMER LASER LZS ABBOTT MEDICAL OPTICS 0030-1479

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other