BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT DELIVERY DEVICE (LDD)

    MDR report key: 18758367 · Received February 22, 2024

    Report

    Report Number
    3012712027-2024-00025
    Event Type
    Injury
    Date Received
    February 22, 2024
    Date of Event
    January 25, 2024
    Report Date
    March 26, 2024
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS REPORTED IN SECTIONS A1, A3A, AND B5. CORRECTIONS MADE IN SECTIONS D1 AND D2.

    Description of Event or Problem · 0

    A SITE REPORTED TO RXSIGHT THAT ON (B)(6) 2024, 1-DAY FOLLOWING THE LOCK-IN LIGHT TREATMENT, THE PATIENT COMPLAINED OF ACHY AND SCRATCHY RIGHT EYE (OD) AND PRESENTED IN CLINIC WITH A SINGLE DENDRITE SEEN IN THE RIGHT EYE. ANTIVIRAL MEDICATION WAS PRESCRIBED TO TREAT THE REACTIVATION OF HERPES SIMPLEX OPHTHALMICUS (HSO). RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 01/25/2024.

    Description of Event or Problem · 0

    A SITE REPORTED TO RXSIGHT THAT ON 01/25/2024, 1-DAY FOLLOWING THE LOCK-IN LIGHT TREATMENT, THE PATIENT COMPLAINED OF ACHY AND SCRATCHY RIGHT EYE (OD) AND PRESENTED IN CLINIC WITH A SINGLE DENDRITE SEEN IN THE RIGHT EYE. ANTIVIRAL MEDICATION WAS PRESCRIBED TO TREAT THE REACTIVATION OF HERPES SIMPLEX OPHTHALMICUS (HSO). RXSIGHT'S FIRST AWARENESS OF THIS EVENT FOR THE RIGHT EYE WAS ON (B)(6) 2024. A SITE REPORTED TO RXSIGHT THAT FOLLOWING THE LOCK-IN LIGHT TREATMENT, THE PATIENT DEVELOPED A DENDRITE IN THE LEFT EYE (OS). ANTIVIRAL MEDICATION WAS PRESCRIBED TO TREAT THE REACTIVATION OF HERPES SIMPLEX OPHTHALMICUS (HSO). RXSIGHT'S FIRST AWARENESS OF THIS EVENT FOR THE LEFT EYE WAS ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67818 LIGHT DELIVERY DEVICE (LDD) LIGHT DELIVERY DEVICE (LDD) PZK RXSIGHT, INC. 61002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention