BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLY ADAPTIVE CATARACT TREATMENT SYSTEM

    MDR report key: 23818481 · Received December 16, 2025

    Report

    Report Number
    3009026057-2025-00060
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    November 24, 2025
    Report Date
    December 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
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF PROCEDURE CONFIRMS BED ORIENTATION AT -90 DEGREES ALTERING THE AXIS OF THE PATIENTS TRUE POSITIONING WHICH WAS ACTUALLY 0 DEGREES TO THE SYSTEM. POP UP INDICATED TO STAFF THAT THE BED POSITIONING WAS -90 DEGREES DIFFERENT FROM PREVIOUS CASE BUT DID NOT RE-ORIENT THE BED POSITIONING PRIOR TO TREATING WHICH IN TURN CREATED INTELLIAXIS NUBS 90 DEGREES OFF AXIS ON PROC#: (B)(6) AND ARCUATES 90 DEGREES OFF AXIS ON PROC#: (B)(6). ONCE DOCTOR WAS UNDER THE MICROSCOPE, HE USED CALLISTO TO VERIFY THE ALIGNMENT, AT WHICH POINT THE DISCREPANCY WAS NOTED. THE LENS WAS ULTIMATELY PLACED AT THE CORRECT AXIS, AND NO ADDITIONAL FOLLOW-UP CARE WAS REQUIRED SYSTEM FUNCTIONED AS DESIGNED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, DOCTOR (B)(6) -C21U) REPORTED TO CAS THAT DURING SURGERY, THEY NOTED THAT THE ARCUATE INCISIONS APPEARED TO BE APPROXIMATELY 90 DEGREES OFF FROM THE INTENDED POSITIONING BASED ON THE APPROVED SURGICAL PLAN FOR THE LASER DURING PROCEDURE IDS#: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2282799 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