BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 20868949 · Received December 6, 2024

    Report

    Report Number
    3012712027-2024-00236
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    October 16, 2024
    Report Date
    February 3, 2026
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020685
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE MANUFACTURING LOT WAS REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. MANUFACTURER REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS SUBMITTED TO PROVIDE THE RESULTS OF THE INVESTIGATION. UPDATES TO SECTIONS D9, H3 AND H6. THE EXPLANTED LAL WAS RETURNED TO RXSIGHT. A VISUAL INSPECTION WAS PERFORMED AND NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 0

    A SITE REPORTED TO RXSIGHT THAT A PATIENT WITH A HISTORY OF DYSFUNCTIONAL TEAR SYNDROME AND POSTERIOR CAPSULAR OPACIFICATION (PCO) HAD THEIR LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +20.5D) EXPLANTED FROM THE RIGHT EYE DUE TO UNHAPPINESS WITH QUALITY OF VISION; A NEW LAL WAS IMPLANTED AS A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622850 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT, INC. 60005 L07-005433 00818806020685

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention