BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 12426051 · Received September 3, 2021

    Report

    Report Number
    3012712027-2021-00049
    Event Type
    Injury
    Date Received
    September 3, 2021
    Date of Event
    July 27, 2021
    Report Date
    September 3, 2021
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020067
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    SITE REPORTED BILATERAL PATIENT HAD THE LIGHT ADJUSTABLE LENSES EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. BOTH OF THE LENSES WERE EXPLANTED (RIGHT EYE EXPLANTED ON (B)(6) 2021; LEFT EYE EXPLANTED ON (B)(6) 2021). RXSIGHT'S AWARENESS DATE WAS 8/10/2021. BOTH EXPLANTED LENSES WERE RETURNED FOR EVALUATION. VISUAL INSPECTION AND OPTICAL TESTING OF THE RETURNED LENSES FOUND NO ISSUES WITH THE LENSES.

    Description of Event or Problem · 0

    SITE REPORTED BILATERAL PATIENT HAD THE LIGHT ADJUSTABLE LENSES EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. BOTH OF THE LENSES WERE EXPLANTED (RIGHT EYE EXPLANTED ON (B)(6) 2021; LEFT EYE EXPLANTED ON (B)(6) 2021). RXSIGHT'S AWARENESS DATE WAS 8/10/2021.

    Additional Manufacturer Narrative · 1

    SITE REPORTED BILATERAL PATIENT HAD THE LIGHT ADJUSTABLE LENSES EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. BOTH OF THE LENSES WERE EXPLANTED (RIGHT EYE EXPLANTED (B)(6) 2021; LEFT EYE EXPLANTED (B)(6) 2021). RXSIGHT'S AWARENESS DATE WAS 8/10/2021. THE DEVICE HISTORY RECORD FOR THE LENSES WERE REVIEWED. NO ISSUES WERE NOTED. RIGHT EYE: SERIAL NUMBER: (B)(4), LOT NUMBER: L07-001723, IMPLANT DATE: (B)(6) 2021, MFG DATE: 7/9/2020, EXPIRATION DATE: 6/30/2023, EXPLANT DATE: (B)(6) 2021, UDI: (B)(4). LEFT EYE: SERIAL NUMBER: (B)(4). LOT NUMBER: L02-001448, IMPLANT DATE: (B)(6) 2021, MFG DATE: 12/5/2019, EXPIRATION DATE: 11/30/2022, EXPLANT DATE: (B)(6) 2021, UDI: (B)(4). THE LENSES HAVE BEEN RECEIVED AND ARE CURRENTLY BEING EVALUATED.

    Description of Event or Problem · 1

    SITE REPORTED BILATERAL PATIENT HAD THE LIGHT ADJUSTABLE LENSES EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. BOTH OF THE LENSES WERE EXPLANTED (RIGHT EYE EXPLANTED (B)(6) 2021; LEFT EYE EXPLANTED (B)(6) 2021). RXSIGHT'S AWARENESS DATE WAS 8/10/2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320821 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS PZK RXSIGHT, INC. 60005 L02-001723 00818806020067

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention