BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 13938479 · Received March 29, 2022

    Report

    Report Number
    3012712027-2022-00012
    Event Type
    Injury
    Date Received
    March 29, 2022
    Date of Event
    January 11, 2022
    Report Date
    March 25, 2022
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SITE REPORTED BILATERAL PATIENT HAD THE LIGHT ADJUSTABLE LENSES EXPLANTED DUE TO RESIDUAL REFRACTIVE ERROR. ANOTHER LAL WAS IMPLANTED IN THE RIGHT EYE DURING THE EXCHANGE ON (B)(6) 2022 AND ANOTHER LAL WAS IMPLANTED IN THE LEFT EYE DURING THE EXCHANGE ON (B)(6) 2022. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURRED ON (B)(6) 2022. THE DEVICE HISTORY RECORD FOR THE LENSES WERE REVIEWED. NO ISSUES WERE NOTED. RIGHT EYE. SERIAL NUMBER: (B)(4). LOT NUMBER: L02-001723. IMPLANT DATE: (B)(6) 2021. MFG DATE: 7/9/2020. EXPIRATION DATE: 6/30/23. EXPLANT DATE: (B)(6) 2022. UDI: (B)(4). LEFT EYE. SERIAL NUMBER: (B)(4). LOT NUMBER: L02-001842. IMPLANT DATE: (B)(6) 2021. MFG DATE: 9/22/2020. EXPIRATION DATE: 8/31/2023. EXPLANT DATE: (B)(6) 2022. UDI: (B)(4). 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 DUE TO RESIDUAL REFRACTIVE ERROR. ANOTHER LAL WAS IMPLANTED IN THE RIGHT EYE DURING THE EXCHANGE ON (B)(6) 2022 AND ANOTHER LAL WAS IMPLANTED IN THE LEFT EYE DURING THE EXCHANGE ON (B)(6) 2022. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURRED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749145 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT, INC. 60005 L02-001723 00818806020067

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention