BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 13047908 · Received December 20, 2021

    Report

    Report Number
    3012712027-2021-00085
    Event Type
    Injury
    Date Received
    December 20, 2021
    Date of Event
    August 11, 2021
    Report Date
    December 13, 2021
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020081
    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

    SITE REPORTED THAT A LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS 12/1/2021. DEVICE HISTORY RECORD FOR THE LENS WAS REVIEWED. NO ISSUES WERE NOTED. THE LENS IS IN THE PROCESS OF BEING RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    SITE REPORTED THAT A LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS (B)(6) 2021. THE EXPLANTED LENS WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND OPTICAL TESTING OF THE RETURNED LENS CONFIRMED THE PRESENCE OF AN AMBIENT ZONE ON THE LENS, WHICH IS INDICATIVE OF EXPOSURE OF THE LENS TO AMBIENT UV LIGHT PRIOR TO LOCK IN.

    Description of Event or Problem · 0

    SITE REPORTED THAT A LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON 12/1/2021.

    Description of Event or Problem · 0

    SITE REPORTED THAT A LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1943965 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS PZK RXSIGHT, INC. 60005 L02-001774 00818806020081

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention