BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS+ (LAL+)

    MDR report key: 24069947 · Received January 14, 2026

    Report

    Report Number
    3012712027-2026-00012
    Event Type
    Injury
    Date Received
    January 14, 2026
    Date of Event
    December 15, 2025
    Report Date
    May 29, 2026
    Manufacturer
    RXSIGHT INC.
    Product Code
    PZK
    UDI-DI
    00818806021620
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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), +22.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO MONOCULAR DIPLOPIA. A NEW LAL+ (SN (B)(6), +21.5D) WAS IMPLANTED AS A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70908 LIGHT ADJUSTABLE LENS+ (LAL+) LIGHT ADJUSTABLE LENS+ (LAL+) PZK RXSIGHT INC. 60007 L08-007965 00818806021620

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention