BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION 3E CONSOLE

    MDR report key: 10864090 · Received November 18, 2020

    Report

    Report Number
    9615659-2020-00008
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    December 18, 2018
    Report Date
    November 11, 2020
    Manufacturer
    MORIA SA
    Product Code
    HMY
    PMA / PMN Number
    K040297
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS THE RESULT OF A HISTORIC REVIEW BASED ON COMPANY INTERNAL CORRECTIVE & PREVENTIVE ACTION (B)(4).

    Description of Event or Problem · 1

    HEALTHCARE PROVIDER REPORTED THEY HAD 'FREE CAP' DURING LASIK SURGERY, DID NOT DO ABLASION, SENT IN EVOLUTION 3E CONSOLE FOR EVALUATION. PATIENT WAS RESCHEDULED FOR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328966 EVOLUTION 3E CONSOLE EVOLUTION 3E CONSOLE HMY MORIA SA 19380 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other