BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS+ (LAL+)

    MDR report key: 22160348 · Received June 6, 2025

    Report

    Report Number
    3012712-2025-00150
    Event Type
    Injury
    Date Received
    June 6, 2025
    Date of Event
    May 8, 2025
    Report Date
    February 5, 2026
    Manufacturer
    RXSIGHT INC.
    Product Code
    PZK
    UDI-DI
    00818806021668
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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).

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION TO THE FOLLOWING SECTIONS: D9, H3, H6, AND H11. THE LAL WAS CUT INTO MULTIPLE PIECES DURING EXPLANTATION. NO DEVICE PROBLEM WAS FOUND DURING VISUAL INSPECTION. NO ADDITIONAL EVALUATION WAS PERFORMED DUE TO THE CONDITION OF THE RETURNED LENS PIECES. THE MFR REPORT# IN THE INITIAL REPORT WAS INCORRECTLY WRITTEN AS CFN-BASED 3012712-2025-00150, AND IT SHOULD BE FEI-BASED 3012712027-2025-00150 INSTEAD. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +24.0 D) WAS EXPLANTED DUE TO BLURRY DISTANCE VISION. A NEW LAL (SN (B)(6), +23.5D) WAS IMPLANTED AS A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462900 LIGHT ADJUSTABLE LENS+ (LAL+) LIGHT ADJUSTABLE LENS+ (LAL+) PZK RXSIGHT INC. 60007 L08-005852 00818806021668

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention