BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 12820165 · Received November 16, 2021

    Report

    Report Number
    3012712027-2021-00074
    Event Type
    Injury
    Date Received
    November 16, 2021
    Date of Event
    August 10, 2021
    Report Date
    November 15, 2021
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020173
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SITE REPORTED AN LAL WAS PIGGYBACKED WITH A STANDARD IMPLANT AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S AWARENESS OF THE EVENT WAS (B)(6) 2021. THE DEVICE HISTORY RECORD FOR THE LENS WAS REVIEWED AND NO ISSUES WERE NOTED. THE LENS REMAINS IMPLANTED IN THE PATIENT'S EYE.

    Description of Event or Problem · 0

    THE SITE REPORTED AN LAL WAS PIGGYBACKED WITH A STANDARD IMPLANT AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S AWARENESS OF THE EVENT WAS (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719778 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT, INC. 60005 L02-001753 00818806020173

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention