BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 24378547 · Received February 18, 2026

    Report

    Report Number
    3012712027-2026-00054
    Event Type
    Injury
    Date Received
    February 18, 2026
    Date of Event
    December 3, 2025
    Report Date
    February 18, 2026
    Manufacturer
    RXSIGHT INC.
    Product Code
    PZK
    UDI-DI
    00818806020623
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 ((B)(6), +17.5D) WAS IMPLANTED BACKWARDS IN THE RIGHT EYE ON (B)(6) 2025. THE LENS WAS SUCCESSFULLY FLIPPED TO THE CORRECT ORIENTATION DURING A SECONDARY SURGERY ON (B)(6) 2026. DUE TO INSTABILITY OF THE CAPSULAR BAG AND ZONULES, THE LAL WAS PLACED IN THE SULCUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140701 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT INC. 60005 L07-007518 00818806020623

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention