BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 24216105 · Received January 29, 2026

    Report

    Report Number
    3012712027-2026-00053
    Event Type
    Injury
    Date Received
    January 29, 2026
    Report Date
    January 29, 2026
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    RXSIGHT BECAME AWARE OF A PATIENT WHO POSTED ANONYMOUSLY ON SOCIAL MEDIA THAT THEY UNDERWENT 2 SURGERIES TO REPOSITION A DISLOCATED LIGHT ADJUSTABLE LENS (LAL) AND THEN A THIRD SURGERY TO EXPLANT THE LAL. DUE TO THE PATIENT'S ANONYMITY AND LIMITED INFORMATION AVAILABLE, RXSIGHT IS UNABLE TO DETERMINE IF THIS COMPLAINT HAS BEEN PREVIOUSLY REPORTED IN A MEDICAL DEVICE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271304 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT, INC. 60005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention