BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALCON EX 500

    MDR report key: 4488162 · Received February 3, 2015

    Report

    Report Number
    4488162
    Event Type
    Injury
    Date Received
    February 3, 2015
    Date of Event
    December 16, 2014
    Report Date
    January 5, 2015
    Manufacturer
    ALCON
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT PRK ENHANCEMENT OVER A PREVIOUS LASIK WITH THE EX500 LASER (B)(6) 2014, PT PRESENTED 1 WEEK POST OP COMPLAINING OF DISCOMFORT OD. (B)(6) NOTED STAINING AND INFLAMMATION/INFILTRATE AT FLAP EDGES OU WITH OD>OS. INCREASED THE ZYMAXID TO QH, PRED FORTE QH, DOXYCYCLINE QID AND ERYTHROMYCIN UNG HS, ORAL PRED STARTED AT 1 WEEK POST OP. PT SEEN (B)6) 2014 VASC 20/70 OD, 20/60 OS, PH 20/25 OD, 20/25 OS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79572 ALCON EX 500 EX 500 LZS ALCON EX500

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention