BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLY ADAPTIVE CATARACT TREATMENT SYSTEM

    MDR report key: 23490017 · Received November 6, 2025

    Report

    Report Number
    3009026057-2025-00050
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    October 17, 2025
    Report Date
    November 3, 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
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF PROCEDURE ID: (B)(6) SHOWS SOME PATIENT MOVEMENT AT THE TIME THE FIRST ARCUATE IS CREATED SHOWING SOME SLIGHT POSTERIOR BREAKTHROUGH. THE SECOND INCISION APPEARS INTACT. PROC ID: (B)(6) SHOWS NO SIGN OF POSTERIOR BREAKTHROUGH ALTHOUGH MAY HAVE HAD A SLIM BED DEPTH DUE TO PATIENT MOVEMENT. PERFORATION FOR THE SECOND INCISION ON (B)(6) MAY HAVE BEEN CAUSED BY OPENING THE INCISION AT THE TIME OF THE CATARACT PROCEDURE. SURGEON CAN TAKE FOOT OFF THE PEDAL AND PAUSE/STOP PROCEDURE AND MANAGE PATIENT MOVEMENT AND THEN RESUME THE PROCEDURE AT ANY TIME. RECOMMENDED INSTRUMENT FOR OPENING ARCUATES IS A SINSKY DUE TO ITS SHALLOW AND BLUNT TIP TO AVOID PERFORATION IN THE OR. SYSTEM FUNCTIONED AS DESIGNED. NO FURTHER CLINICAL FOLLOW-UP REQUIRED.

    Description of Event or Problem · 0

    ON 10/17/2025, DOCTOR (B)(6) -C21U) REPORTED TO CAS THAT A PERFORATED LRI WAS NOTED DURING PROCEDURE IDS#: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562664 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