BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 11984472 · Received June 11, 2021

    Report

    Report Number
    3012712027-2021-00023
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    May 17, 2021
    Report Date
    June 11, 2021
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020203
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS IN THE PATIENT'S RIGHT EYE WAS EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. ANOTHER LIGHT ADJUSTABLE LENS WAS IMPLANTED DURING THE EXCHANGE.DEVICE HISTORY RECORD FOR THE LENS WAS REVIEWED. NO ISSUES WERE NOTED.THE EXPLANTED LENS WAS RETURNED AND RECEIVED IN MULTIPLE FRAGMENTS. THE LENS FRAGMENTS WERE VISUALLY INSPECTED AND THE OPTICAL QUALITY WAS ASSESSED. NO ISSUES WERE NOTED.

    Description of Event or Problem · 1

    SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS IN THE PATIENT'S RIGHT EYE WAS EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. ANOTHER LIGHT ADJUSTABLE LENS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882976 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT, INC. 60005 L02-001476 00818806020203

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention