BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 24506893 · Received March 4, 2026

    Report

    Report Number
    3012712027-2026-00076
    Event Type
    Injury
    Date Received
    March 4, 2026
    Date of Event
    February 2, 2026
    Report Date
    March 4, 2026
    Manufacturer
    RXSIGHT INC.
    Product Code
    PZK
    UDI-DI
    00818806020623
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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).

    Description of Event or Problem · 0

    A SITE REPORTED TO RXSIGHT THAT A PATIENT WITH HISTORY OF TRAUMATIC CATARACT WAS IMPLANTED WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +17.5D) AS A REPLACEMENT FOR A MONOFOCAL LENS FROM ANOTHER MANUFACTURER THAT HAD DISLOCATED. POST-OPERATIVELY, THE LAL WAS OBSERVED TO BE DISLOCATED INTO THE POSTERIOR POLE. ON (B)(6) 2026, THE LAL WAS EXPLANTED AND A NEW LAL (SN (B)(6), +17.5D) WAS IMPLANTED VIA YAMANE TECHNIQUE AS A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT INC. 60005 L07-005343 00818806020623

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention