BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 12968836 · Received December 9, 2021

    Report

    Report Number
    3012712027-2021-00081
    Event Type
    Injury
    Date Received
    December 9, 2021
    Report Date
    December 7, 2021
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020159
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED AS TO THE REASON FOR THE EXPLANT. RXSIGHT'S FIRST AWARENESS WAS 11/30/2021. THE EXPLANTED LENS WAS RETURNED FOR EVALUATION. VISUAL AND OPTICAL TESTING VERIFIED THE PRESENCE OF A ZONE NEAR THE CENTER OF THE LENS. THE PRESENCE OF THE ZONE IS INDICATIVE OF LENS EXPOSURE TO AMBIENT UV LIGHT.

    Additional Manufacturer Narrative · 0

    THE SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED AS TO THE REASON FOR THE EXPLANT. RXSIGHT'S FIRST AWARENESS WAS (B)(6) 2021. THE DEVICE HISTORY RECORD FOR THE LENS WAS REVIEWED. NO ISSUES WERE NOTED. THE LENS IS CURRENTLY BEING EVALUATED.

    Description of Event or Problem · 0

    THE SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED AS TO THE REASON FOR THE EXPLANT. RXSIGHT'S FIRST AWARENESS WAS 11/30/2021.

    Description of Event or Problem · 0

    THE SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED AS TO THE REASON FOR THE EXPLANT. RXSIGHT'S FIRST AWARENESS WAS (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866759 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS PZK RXSIGHT, INC. 60005 L02-001494 00818806020159

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other