BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 12861044 · Received November 23, 2021

    Report

    Report Number
    3012712-2021-00078
    Event Type
    Injury
    Date Received
    November 23, 2021
    Date of Event
    October 22, 2021
    Report Date
    November 22, 2021
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020203
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SITE REPORTED THE LIGHT ADJUSTABLE LENS WAS EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS (B)(6) 2021. DEVICE HISTORY RECORD FOR THE LENS WAS REVIEWED. NO ISSUES WERE NOTED. THE EXPLANTED LENS WAS RETURNED FOR EVALUATION. VISUAL AND OPTICAL TESTING VERIFIED THE PRESENCE OF A ZONE NEAR THE CENTER OF THE LENS. THE PRESENCE OF THE ZONE IS INDICATIVE OF LENS EXPOSURE TO AMBIENT UV LIGHT.

    Description of Event or Problem · 0

    SITE REPORTED THE LIGHT ADJUSTABLE LENS WAS EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759401 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT, INC. 60005 L02-001753 00818806020203

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention