BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 18651886 · Received February 6, 2024

    Report

    Report Number
    3012712027-2024-00009
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    January 8, 2024
    Report Date
    February 6, 2024
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER THE IMPLANTATION OF THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +14.0D) ON (B)(6) 2022, THE PATIENT UNDERWENT MULTIPLE PROCEDURES INCLUDING A YAG CAPSULOTOMY ON 04/10/2023, A WAVEFRONT GUIDED PHOTOREFRACTIVE KERATECTOMY (PRK) TO TREAT HIGHER ORDER ABERRATIONS (HOA) ON 06/14/2023, AND A YAG EPI BARRIER PROCEDURE FOR EPITHELIAL IN-GROWTH ON 10/25/2023, BUT THE LAL NEVER RECEIVED A LOCKIN TREATMENT. ON 11/08/2023, APPROXIMATELY 10 MONTHS AFTER LAL IMPLANTATION, THE PHYSICIAN REPORTED A CENTRAL POWER CHANGE. THE LAL WAS EXPLANTED BUT WAS NOT RETURNED TO RXSIGHT FOR FURTHER EXAMINATION. THE DEVICE HISTORY RECORD FOR THE MANUFACTURING LOT WAS REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. MANUFACTURER REFERENCE #: 3941.

    Description of Event or Problem · 0

    A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +14.0D) WAS EXPLANTED. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 01/08/2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1954930 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT, INC. 60005 L07-003259

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention