BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 12661716 · Received October 19, 2021

    Report

    Report Number
    3012712027-2021-00063
    Event Type
    Injury
    Date Received
    October 19, 2021
    Date of Event
    September 1, 2021
    Report Date
    October 18, 2021
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN REPORTED DURING IMPLANTATION OF THE LAL, THE POSTERIOR CAPSULE WAS RUPTURED WITH THE LEADING HAPTIC OF THE LENS. THE PHYSICIAN WAS ABLE TO IMPLANT THE LENS INTO THE SULCUS WITHOUT FURTHER ISSUE. RXSIGHT'S FIRST AWARENESS OF THE ISSUE WAS 9/22/2021. THE DEVICE HISTORY RECORD FOR THE LENS COULD NOT BE REVIEWED AS THE SITE DID NOT PROVIDE THE SERIAL NUMBER OF THE LENS. THE LENS REMAINS IMPLANTED IN THE PATIENT'S EYE.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED DURING IMPLANTATION OF THE LAL, THE POSTERIOR CAPSULE WAS RUPTURED WITH THE LEADING HAPTIC OF THE LENS. THE PHYSICIAN WAS ABLE TO IMPLANT THE LENS INTO THE SULCUS WITHOUT FURTHER ISSUE. RXSIGHT'S FIRST AWARENESS OF THE ISSUE WAS 9/22/2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559342 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT, INC. 60005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other