BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 24747876 · Received March 31, 2026

    Report

    Report Number
    3012712027-2026-00137
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 31, 2026
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020630
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE MANUFACTURING LOT WAS REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6) , +18.0D) WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809614 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT, INC. 60005 L07-007219 00818806020630

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention