BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS+

    MDR report key: 24007829 · Received January 8, 2026

    Report

    Report Number
    3012712027-2026-00009
    Event Type
    Injury
    Date Received
    January 8, 2026
    Date of Event
    September 1, 2024
    Report Date
    January 8, 2026
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    RXSIGHT BECAME AWARE OF A BILATERALLY IMPLANTED PATIENT WHO HAD THEIR LIGHT ADJUSTABLE LENS+ (LAL+) EXPLANTED FROM THEIR NON-DOMINANT EYE DUE TO VISUAL DISTURBANCE AND THE PATIENT'S DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63441 LIGHT ADJUSTABLE LENS+ LIGHT ADJUSTABLE LENS+ PZK RXSIGHT, INC. 60007

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention