BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 14364063 · Received May 11, 2022

    Report

    Report Number
    3012712027-2022-00018
    Event Type
    Injury
    Date Received
    May 11, 2022
    Date of Event
    April 12, 2022
    Report Date
    May 10, 2022
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020135
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SITE REPORTED A PATIENT WAS NOT FULLY COMPLIANT TO UV SPECTACLE WEAR. THE LIGHT ADJUSTABLE LENS WAS EXPLANTED ON (B)(6) 2022. RXSIGHT'S AWARENESS OF THE EVENT WAS 4/13/2022. THE DEVICE HISTORY RECORD FOR THE LENS WAS REVIEWED. NO ISSUES WERE NOTED. THE EXPLANTED LENS WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND OPTICAL TESTING OF THE RETURNED LENS CONFIRMED THE PRESENCE OF AN AMBIENT ZONE ON THE LENS, WHICH IS INDICATIVE OF EXPOSURE OF THE LENS TO AMBIENT UV LIGHT PRIOR TO LOCK IN.

    Description of Event or Problem · 0

    SITE REPORTED A PATIENT WAS NOT FULLY COMPLIANT TO UV SPECTACLE WEAR. THE LIGHT ADJUSTABLE LENS WAS EXPLANTED ON (B)(6) 2022. RXSIGHT'S AWARENESS OF THE EVENT WAS 4/13/2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1791428 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT, INC. 60005 L02-001471 00818806020135

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention