BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNI GLAUCOMA TREATMENT SYSTEM

    MDR report key: 9839972 · Received March 16, 2020

    Report

    Report Number
    MW5093771
    Event Type
    Injury
    Date Received
    March 16, 2020
    Date of Event
    January 27, 2020
    Report Date
    March 12, 2020
    Manufacturer
    OMNI / SIGHT SCIENCES, INC.
    Product Code
    HMZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A TRABECULECTOMY PROCEDURE (B)(6) 2020. EXPERIENCED A POSSIBLE OMNI SURGICAL DEVICE PRODUCT FAILURE. PT RETURNED (B)(6) 2020 RELATED TO INCREASED OCULAR PRESSURE. SECOND PROCEDURE TO INSERT EXPRESS SHORT ON (B)(6) 2020 WAS SUCCESSFUL. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301584 OMNI GLAUCOMA TREATMENT SYSTEM TRABECULOTOME HMZ OMNI / SIGHT SCIENCES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention