BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 24683371 · Received March 25, 2026

    Report

    Report Number
    3012712027-2026-00128
    Event Type
    Injury
    Date Received
    March 25, 2026
    Date of Event
    February 24, 2026
    Report Date
    March 24, 2026
    Manufacturer
    RXSIGHT INC.
    Product Code
    PZK
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 CAPSULE TEAR OCCURRED ON (B)(6) 2026 WHEN THE SURGEON WAS REPLACING AN EXISTING IOL WITH THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.0D) FOR A PATIENT WHO HAD A WEAK CAPSULAR BAG. A SECONDARY SURGERY WAS PERFORMED ON (B)(6) 2026 TO FIXATE THE LAL USING THE YAMANE TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747616 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT INC. 60005 L07-009277

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Disability