BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 11645181 · Received April 9, 2021

    Report

    Report Number
    3012712027-2021-00017
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    March 15, 2021
    Report Date
    April 9, 2021
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020180
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS IN THE PATIENT'S LEFT EYE WAS EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. ANOTHER LIGHT ADJUSTABLE LENS WAS IMPLANTED IN THE EXCHANGE. THE EXPLANTED LENS WAS RETURNED FOR EVALUATION. VISUAL AND OPTICAL TESTING VERIFIED THE PRESENCE OF A ZONE NEAR THE CENTER OF THE LENS. THE PRESENCE OF THE ZONE IS INDICATIVE OF EXPOSURE OF THE LENS TO AMBIENT UV LIGHT.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS IN THE PATIENT'S LEFT EYE WAS EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. ANOTHER LIGHT ADJUSTABLE LENS WAS IMPLANTED IN THE EXCHANGE. DEVICE HISTORY RECORD FOR THE LENS WAS REVIEWED. NO ISSUES WERE NOTED. THE EXPLANTED LENS HAS BEEN RECEIVED AND IS CURRENTLY UNDER EVALUATION.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541508 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT, INC. 60005 L02-001212 00818806020180

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention