BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 15749826 · Received November 7, 2022

    Report

    Report Number
    3012712027-2022-00050
    Event Type
    Injury
    Date Received
    November 7, 2022
    Date of Event
    October 14, 2022
    Report Date
    November 7, 2022
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020708
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE SITE REPORTED THAT INCORRECT MANIFEST REFRACTIONS WERE ENTERED INTO THE LDD. BCVA VALUES FOR THE PATIENT WERE 20/20 THROUGHOUT THE COURSE OF THE LIGHT TREATMENT. AFTER THE LOCK-IN#1 VISIT ((B)(6) 2022), THE SURGEON DECIDED TO EXPLANT THE LENS AND IMPLANT A NEW LAL WITH THE SAME 21.5D POWER ON (B)(6) 2022. THE EXPLANTED LENS (SN: (B)(4)) IS CURRENTLY UNDERGOING EVALUATION BY RXSIGHT. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL) HAS BEEN EXPLANTED DUE TO INCORRECT MANIFEST REFRACTION (MR) VALUES BEING ENTERED INTO THE LDD DURING LIGHT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2529491 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT, INC. 60005 L07-003835 00818806020708

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention