BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLY ADAPTIVE CATARACT TREATMENT SYSTEM

    MDR report key: 23802445 · Received December 15, 2025

    Report

    Report Number
    3009026057-2025-00062
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    December 4, 2025
    Report Date
    December 12, 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
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF PROCEDURE # (B)(6) SHOWS AN INCISION DEPTH OF 85% WITH A MINIMUM RESIDUAL BED OF 111 M. THE BUBBLE PATTERN APPEARS NORMAL, AND THERE IS NO INDICATION OF A FULL-THICKNESS ARCUATE INCISION. SUTURE WAS PLACED BY THE SURGEON. THE SYSTEM FUNCTIONED AS DESIGNED AND PATIENT IS DOING WELL POST. NO FURTHER CLINICAL FOLLOW UP REQUIRED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, DOCTOR ((B)(4)) REPORTED TO (B)(6) THAT THEY EXPERIENCED A FULL THICKNESS ARCUATE INCISION DURING PROCEDURE ID # (B)(6). SITE IS SEEKING A REVIEW OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283965 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