BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 12368535 · Received August 25, 2021

    Report

    Report Number
    3012712027-2021-00046
    Event Type
    Injury
    Date Received
    August 25, 2021
    Report Date
    August 25, 2021
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020166
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SITE REPORTED BILATERAL PATIENT INADVERTENTLY EXPOSED THE IMPLANTED LIGHT ADJUSTABLE LENSES TO AMBIENT UV LIGHT. BOTH OF THE LENSES WERE EXPLANTED. RXSIGHT'S AWARENESS DATE WAS 8/2/2021. THE EXPLANTED LENSES WERE RETURNED FOR EVALUATION. VISUAL INSPECTION AND OPTICAL TESTING OF BOTH RETURNED LENSES CONFIRMED THE PRESENCE OF AMBIENT ZONES ON THE LENSES, WHICH IS INDICATIVE OF EXPOSURE OF THE LENSES TO AMBIENT UV LIGHT PRIOR TO LOCK IN.

    Description of Event or Problem · 0

    SITE REPORTED BILATERAL PATIENT INADVERTENTLY EXPOSED THE IMPLANTED LIGHT ADJUSTABLE LENSES TO AMBIENT UV LIGHT. BOTH OF THE LENSES WERE EXPLANTED. RXSIGHT'S AWARENESS DATE WAS 8/2/2021.

    Additional Manufacturer Narrative · 1

    SITE REPORTED BILATERAL PATIENT INADVERTENTLY EXPOSED THE IMPLANTED LIGHT ADJUSTABLE LENSES TO AMBIENT UV LIGHT. BOTH OF THE LENSES WERE EXPLANTED. RXSIGHT'S AWARENESS DATE WAS 8/2/2021. THE DEVICE HISTORY RECORD FOR THE LENSES WERE REVIEWED. NO ISSUES WERE NOTED. SERIAL NUMBER: (B)(4), LOT NUMBER: L02-001937, IMPLANT DATE: UNKNOWN, MFG DATE: 11/20/2020, EXPIRATION DATE: 10/31/2023, EXPLANT DATE: UNKNOWN, UDI: (B)(4). SERIAL NUMBER: (B)(4), LOT NUMBER: L02-001415, IMPLANT DATE: UNKNOWN, MFG DATE: 11/16/2019, EXPIRATION DATE: 10/31/2022, EXPLANT DATE: UNKNOWN, UDI: (B)(4). THE LENSES HAVE BEEN RECEIVED AND ARE CURRENTLY BEING EVALUATED.

    Description of Event or Problem · 1

    SITE REPORTED BILATERAL PATIENT INADVERTENTLY EXPOSED THE IMPLANTED LIGHT ADJUSTABLE LENSES TO AMBIENT UV LIGHT. BOTH OF THE LENSES WERE EXPLANTED. RXSIGHT'S AWARENESS DATE WAS 8/2/2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265139 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS PZK RXSIGHT, INC. 60005 L02-001937 00818806020166

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention