BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 24402997 · Received February 20, 2026

    Report

    Report Number
    3012712027-2026-00061
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    January 22, 2026
    Report Date
    February 20, 2026
    Manufacturer
    RXSIGHT INC.
    Product Code
    PZK
    UDI-DI
    00818806020685
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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), +20.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO BLURRY VISION SECONDARY TO LAL DECENTRATION. A NEW LAL WAS IMPLANTED IN THE SULCUS AS A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464902 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT INC. 60005 L07-007062 00818806020685

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention