BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT DELIVERY DEVICE (LDD)

    MDR report key: 24491855 · Received March 2, 2026

    Report

    Report Number
    3012712027-2026-00102
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    January 15, 2026
    Report Date
    March 2, 2026
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020029
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD WAS REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. MANUFACTURER REFERENCE #:(B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED TO RXSIGHT THAT A PATIENT WAS DIAGNOSED WITH HERPES ZOSTER OPHTHALMICUS (HZO) WITH CORNEAL INVOLVEMENT ON (B)(6) 2026 FOLLOWING A RECENT LOCK-IN TREATMENT ON (B)(6) 2026. ANTIVIRAL MEDICATION WAS PRESCRIBED FOR THE PATIENT. ON (B)(6) 2026, PATIENT'S SYMPTOMS WERE RESOLVED. THE TREATING PHYSICIAN KEPT PATIENT ON ANTIVIRAL MEDICATION AS PROPHYLACTIC TREATMENT THROUGH THE FINAL LOCK IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3519 LIGHT DELIVERY DEVICE (LDD) LIGHT DELIVERY DEVICE (LDD) PZK RXSIGHT, INC. 61002-006 00818806020029

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention