BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLY ADAPTIVE CATARACT TREATMENT SYSTEM

    MDR report key: 23853743 · Received December 19, 2025

    Report

    Report Number
    3009026057-2025-00064
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    December 2, 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
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF PROCEDURE (B)(6) SHOWS MOVEMENT THROUGHOUT THE PROCEDURE. PATIENT MOVEMENT OBSERVED DURING THE LASER PROCEDURE IS THE LIKELY CAUSE OF THE REPORTED FULL THICKNESS ARCUATE INCISION. SYSTEM FUNCTIONED AS DESIGNED. NO FURTHER CLINICAL FOLLOW UP REQUIRED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, WHILE CAS WAS ON SITE FOR SURGERY SUPPORT, DOCTOR (B)(6) REPORTED THAT ON (B)(6) 2025, DURING PROCEDURE ID # (B)(6), HE EXPERIENCED A FULL THICKNESS ARCUATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2312067 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