BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLY ADAPTIVE CATARACT TREATMENT SYSTEM

    MDR report key: 25067271 · Received May 4, 2026

    Report

    Report Number
    3009026057-2026-00020
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    December 5, 2025
    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
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF PROCEDURE ID# (B)(6) VIDEO AND IMAGING SHOWS PATIENT MOVEMENT DURING THE FIRST PART OF PROCEDURE AND RIGHT AFTER AK WAS MADE CHANGING EYE POSITIONING FROM THE POINT OF SCANNING. 1 ARCUATE INCISION OF 70 DEGREE @ 35 WAS PROGRAMMED WITH A 600 MICRON FIXED DEPTH AND RESIDUAL 150 MICRON BED DEPTH WITH ENERGY AT 3.0UJ. BUBBLES APPEAR TO BE IN THE ANTERIOR CHAMBER AFTER THE ARCUATE WAS MADE INDICATING POTENTIAL POSTERIOR PENETRATION OF THE CORNEA IN THAT REGION. RECOMMEND REVIEW OF LOCKING PATIENT AND PAUSING TREATMENT DURING MOVEMENT AND ADJUSTING AK DEPTH TO 80% AND ENERGY TO 2.8UJ. SYSTEM FUNCTIONED AS DESINGED. NO FURTHER CLINICAL FOLLOW UP IS REQUIRED.

    Description of Event or Problem · 0

    ON (B)(6) 2026, WHILE CAS WAS ON SITE FOR SURGERY SUPPORT, DOCTOR ((B)(6)) REPORTED THAT THEY NOTED A FULL THICKNESS AK DURING PROCEDURE ID # (B)(6). THIS PROCEDURE WAS PERFORMED ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287987 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