BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIEMER FEMTO LDV

    MDR report key: 18167253 · Received November 19, 2023

    Report

    Report Number
    3005643720-2023-00001
    Event Type
    Injury
    Date Received
    November 19, 2023
    Date of Event
    March 21, 2023
    Report Date
    November 18, 2022
    Manufacturer
    SIE AG, SURGICAL INSTRUMENT ENGINEERING
    Product Code
    OOE
    PMA / PMN Number
    K150323
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT DID NOT RECEIVE ANY OTHER TREATMENT, AND RECENTLY GAVE FEEDBACK THAT HIS VISION WAS CLEARER WHEN WEARING A COMMERCIALLY AVAILABLE SCL LENS.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT CLEAR TREATMENT ON (B)(6) 2023. 6 MONTHS LATER, THE BVA HAS NOT IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511539 ZIEMER FEMTO LDV FEMTO LDV Z8 OOE SIE AG, SURGICAL INSTRUMENT ENGINEERING FEMTO LDV

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R