BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 12064184 · Received June 24, 2021

    Report

    Report Number
    3012712027-2021-00024
    Event Type
    Injury
    Date Received
    June 24, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 24, 2021
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020104
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DOCTOR NOTED AFTER SEVERAL LDD TREATMENTS THAT THE LIGHT ADJUSTABLE LENS WAS IMPLANTED BACKWARDS INTO THE PATIENT'S RIGHT EYE. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LIGHT ADJUSTABLE LENS ON (B)(6) 2021. DEVICE HISTORY RECORD FOR THE LENS WAS REVIEWED. NO ISSUES WERE NOTED. THE EXPLANTED LENS WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND OPTICAL TESTING VERIFIED THAT THE LENS HAD NOT BEEN AFFECTED BY THE LIGHT TREATMENTS DUE TO BEING IMPLANTED BACKWARDS.

    Description of Event or Problem · 1

    DOCTOR NOTED AFTER SEVERAL LDD TREATMENTS THAT THE LIGHT ADJUSTABLE LENS WAS IMPLANTED BACKWARDS INTO THE PATIENT'S RIGHT EYE. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LIGHT ADJUSTABLE LENS ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956144 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT, INC. 60005 L02-001479 00818806020104

    Patients

    Seq Age Sex Outcome Treatment
    1 Other