BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 24743632 · Received March 31, 2026

    Report

    Report Number
    3012712027-2026-00142
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    March 4, 2026
    Report Date
    March 31, 2026
    Manufacturer
    RXSIGHT INC.
    Product Code
    PZK
    UDI-DI
    00818806020715
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 WAS IMPLANTED WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.0D) IN THE LEFT EYE ON (B)(6) 2023. THE PATIENT COMPLETED TWO LIGHT ADJUSTMENTS ON (B)(6) 2024 AND DID NOT RETURN FOR LOCK-IN LIGHT TREATMENTS. APPROXIMATELY 30 MONTHS AFTER IMPLANTATION, THE PATIENT RETURNED TO CLINIC COMPLAINING OF BLURRY VISION. ON (B)(6) 2026 THE PHYSICIAN NOTED IOL SURFACE CHANGES CONSISTENT WITH POLYMERIZATION. THE LAL WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2026 AND A NEW LAL+ (SN (B)(6), +23.5D) WAS IMPLANTED AS A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803987 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT INC. 60005 L07-004799 00818806020715

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention