BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLY ADAPTIVE CATARACT TREATMENT SYSTEM

    MDR report key: 23839201 · Received December 18, 2025

    Report

    Report Number
    3009026057-2025-00063
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    December 11, 2025
    Report Date
    December 17, 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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF PROCEDURE ID (B)(6) SHOWS SIGNIFICANT PATIENT MOVEMENT DURING ALL STAGES OF THE PROCEDURE AND DURING ARCUATE INCISIONS. THIS IS LIKELY DUE TO THE PID SUCTION RING NOT LOCKED TO THE PID ARM AND MAY HAVE LEAD TO A FULL THICKNESS ARCUATE INCISION. PROPER LOCKING TECHNIQUE SHOULD BE ADDRESSED. SYSTEM FUNCTIONED AS DESIGNED. NO FURTHER CLINICAL FOLLOW UP REQUIRED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, DOCTOR (B)(6) REPORTED TO CAS THAT THEY ENCOUNTERED A PERFORATED AK AND INFERIOR AK DURING PROCEDURE ID # (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244504 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