BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 12447781 · Received September 9, 2021

    Report

    Report Number
    3012712027-2021-00051
    Event Type
    Injury
    Date Received
    September 9, 2021
    Report Date
    September 9, 2021
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020302
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS HAD BEEN EXPLANTED FROM THE PATIENT. UPON FOLLOW-UP, THE SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS HAD BEEN EXPOSED TO AMBIENT UV LIGHT PRIOR TO LOCK IN. RXSIGHT'S FIRST AWARENESS OF THIS WAS 8/17/2021. THE EXPLANTED LENS WAS RETURNED FOR EVALUATION. THE LENS WAS CUT INTO MULTIPLE FRAGMENTS. VISUAL INSPECTION AND OPTICAL TESTING OF THE LENS CONFIRMED THE PRESENCE OF AN AMBIENT ZONE, WHICH IS INDICATIVE OF AMBIENT UV LIGHT EXPOSURE PRIOR TO LOCK IN.

    Description of Event or Problem · 0

    THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS HAD BEEN EXPLANTED FROM THE PATIENT. UPON FOLLOW-UP, THE SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS HAD BEEN EXPOSED TO AMBIENT UV LIGHT PRIOR TO LOCK IN. RXSIGHT'S FIRST AWARENESS OF THIS WAS 8/17/2021.

    Additional Manufacturer Narrative · 1

    THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS HAD BEEN EXPLANTED FROM THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME. RXSIGHT'S FIRST AWARENESS OF THIS WAS 8/17/2021. THE DEVICE HISTORY RECORD FOR THE LENS WAS REVIEWED. NO ISSUES WERE NOTED. THE LENS IS CURRENTLY BEING EVALUATED.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS HAD BEEN EXPLANTED FROM THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME. RXSIGHT'S FIRST AWARENESS OF THIS WAS 8/17/2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343344 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT, INC. 60005 L02-001507 00818806020302

    Patients

    Seq Age Sex Outcome Treatment
    1 Other