BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLY ADAPTIVE CATARACT TREATMENT SYSTEM

    MDR report key: 23489838 · Received November 6, 2025

    Report

    Report Number
    3009026057-2025-00048
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    October 13, 2025
    Report Date
    October 27, 2025
    Manufacturer
    LENSAR, INC.
    Product Code
    OOE
    UDI-DI
    00867744000150
    PMA / PMN Number
    K220259
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF PROCEDURE#: (B)(6) SHOWS DECENTERED DOCKING. THERE ARE NO SIGNS OF A FULL THICKNESS AK PRESENT. SYSTEM FUNCTIONED AS DESIGNED. NO FURTHER CLINICAL FOLLOW-UP REQUIRED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, DOCTOR (B)(6) -C21U) REPORTED TO CAS THAT ON (B)(6) 2025 THEY EXPERIENCED FULL THICKNESS AK DURING PROCEDURE ID#: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385911 ALLY ADAPTIVE CATARACT TREATMENT SYSTEM ALLY ADAPTIVE CATARACT TREATMENT SYSTEM OOE LENSAR, INC. N/A N/A 00867744000150

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other