BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 14643762 · Received June 9, 2022

    Report

    Report Number
    3012712027-2022-00023
    Event Type
    Injury
    Date Received
    June 9, 2022
    Report Date
    June 8, 2022
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020159
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SITE REPORTED THE LIGHT ADJUSTABLE LENS WAS EXPLANTED AS THE PATIENT WAS UNHAPPY WITH THE VISUAL OUTCOME. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS 5/13/2022. DEVICE HISTORY RECORD FOR THE LENS WAS REVIEWED. NO ISSUES WERE NOTED. THE EXPLANTED LENS WAS RETURNED FOR EVALUATION. THE LENS WAS CUT INTO MULTIPLE FRAGMENTS. VISUAL AND OPTICAL TESTING OF THE LENS FOUND NO ISSUE WITH THE LENS.

    Description of Event or Problem · 0

    SITE REPORTED THE LIGHT ADJUSTABLE LENS WAS EXPLANTED AS THE PATIENT WAS UNHAPPY WITH THE VISUAL OUTCOME. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS 5/13/2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195570 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT, INC. 60005 L02-001954 00818806020159

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention