BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLY ADAPTIVE CATARACT TREATMENT SYSTEM

    MDR report key: 25067253 · Received May 4, 2026

    Report

    Report Number
    3009026057-2026-00017
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    April 10, 2026
    Report Date
    April 28, 2026
    Manufacturer
    LENSAR, INC.
    Product Code
    OOE
    UDI-DI
    00867744000150
    PMA / PMN Number
    K220529
    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 #1507 SHOWS BUBBLE BREAK THROUGH INTO THE ANTERIOR CHAMBER ON IMAGING FRAMES 28-29. THE ALIGNMENT CAMERA SHOWS THE SURGEON PROPERLY LOCKING PATIENT AT THE START OF THE PROCEDURE. VIDEO IMAGING SHOWS SOME SLIGHT PATIENT MOVEMENT. ARCUATE DEPTH SETTINGS MAY BE ADJUSTED FROM 85% TO 80% AT THE SURGEON'S DISCRETION TO PROVIDE A LARGER SAFETY MARGIN. SYSTEM FUNCTIONED AS DESIGNED. THE PATIENT IS DOING WELL AFTER A SUTURE WAS PLACED. NO FURTHER CLINICAL FOLLOW UP IS REQUIRED.

    Description of Event or Problem · 0

    ON (B)(6) 2026, DOCTOR (B)(6) REPORTED TO CAS THAT DURING PROCEDURE ID #1507, FULL THICKNESS OCCURRED DURING THE TEMPORAL AK. THEY NOTED THAT A SUTURE WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112533 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