BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLY ADAPTIVE CATARACT TREATMENT SYSTEM

    MDR report key: 23575606 · Received November 17, 2025

    Report

    Report Number
    3009026057-2025-00056
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    November 5, 2025
    Report Date
    November 14, 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
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF PROCEDURE ID# (B)(6) SHOWS VERY BRIGHT CATARACT IN THE SCHEIMPFLUG IMAGING AND PATIENT MOVEMENT DURING CAPSULOTOMY. THIS MAY HAVE CAUSED A DOUBLE CUT, TAGS OR ADHERED AREAS OF THE CAPSULE BUTTON WHICH REQUIRE CAREFUL REMOVAL. CHECKING QUADRANTS WITH A GENTLE PERPENDICULAR PULL AND IF ADHERED A COUNTERCLOCKWISE PEEL TO REMOVE THE CAPSULE BUTTON. IF THE BUTTON IS PULLED WITHOUT CHECKING THIS CAN CREATE MICRO TEARS AT TAGGED OR ADHERED SITES WEAKENING THE CAPSULE. SYSTEM FUNCTIONED AS DESIGNED. NO FURTHER CLINICAL FOLLOW-UP REQUIRED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, DOCTOR (B)(6) REPORTED THAT DURING PROCEDURE ID #(B)(6), THEY RECEIVED MULTIPLE LINES, AND THE CAPSULE SPLIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783116 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