BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 14519401 · Received May 26, 2022

    Report

    Report Number
    3012712027-2022-00020
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    April 21, 2022
    Report Date
    May 24, 2022
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806207531
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SITE REPORTED THE LIGHT ADJUSTABLE LENS HAD BEEN IMPLANTED BACKWARDS INTO THE PATIENT'S EYE. THE LENS WAS REPOSITIONED ON 4/21/2022. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS 4/30/2022. DEVICE HISTORY RECORD FOR THE LENS WAS REVIEWED. NO ISSUES WERE NOTED. THE LENS REMAINS IMPLANTED.

    Description of Event or Problem · 0

    SITE REPORTED THE LIGHT ADJUSTABLE LENS HAD BEEN IMPLANTED BACKWARDS INTO THE PATIENT'S EYE. THE LENS WAS REPOSITIONED ON 4/21/2022. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS 4/30/2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1663683 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT, INC. 60005 L07-003360 00818806207531

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other