BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 24623762 · Received March 17, 2026

    Report

    Report Number
    3012712027-2026-00117
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    February 17, 2026
    Report Date
    March 18, 2026
    Manufacturer
    RXSIGHT INC.
    Product Code
    PZK
    UDI-DI
    00818806020760
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 BEING SUBMITTED TO PROVIDE CORRECTED INFORMATION TO SECTIONS B5 AND D6A. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, (B)(6), +25.0D) WAS IMPLANTED IN THE RIGHT EYE ON (B)(6) 2025. NO LIGHT TREATMENTS WERE PERFORMED BEFORE THE PATIENT RETURNED TO THE CLINIC ON (B)(6) 2026 COMPLAINING OF BLURRY VISION. EXAMINATION REVEALED CENTRAL IOL DISTORTION AFTER REPORTED TANNING BED USE. THE LAL WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2026 AND A NEW LAL (SN: (B)(6), +25.0D) WAS IMPLANTED AS A REPLACEMENT.

    Description of Event or Problem · 0

    A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, (B)(6), +25.0D) WAS IMPLANTED IN THE RIGHT EYE ON (B)(6) 2025. NO LIGHT TREATMENTS WERE PERFORMED BEFORE THE PATIENT RETURNED TO THE CLINIC ON (B)(6) 2026 COMPLAINING OF BLURRY VISION. EXAMINATION REVEALED CENTRAL IOL DISTORTION AFTER REPORTED TANNING BED USE. THE LAL WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2026 AND A NEW LAL (SN (B)(6), +25.0D) WAS IMPLANTED AS A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327200 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT INC. 60005 L07-004559 00818806020760

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention