BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLY ADAPTIVE CATARACT TREATMENT SYSTEM

    MDR report key: 23450676 · Received November 3, 2025

    Report

    Report Number
    3009026057-2025-00046
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    October 9, 2025
    Report Date
    October 27, 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
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF PROCEDURE ID 190 WAS DONE AND SHOWS NO SIGNS OF CORNEAL PERFORATION WHILE PERFORMING THE SINGLE ARCUATE INCISION. THERE IS NO BREAKTHROUGH OF THE POSTERIOR CORNEA. CORNEAL PERFORATION MAY HAVE OCCURRED POST LASER SURGERY AND THEREFORE, DOCTOR PLACED A SUTURE. SYSTEM FUNCTIONED AS DESIGNED. RECOMMEND REVIEWING PROPER OPENING TECHNIQUES WITH SURGEON. PATIENT IS DOING WELL DURING PO VISIT. NO FURTHER CLINICAL FOLLOW UP IS REQUIRED.

    Description of Event or Problem · 0

    ON 10/09/2025, DOCTOR (B)(6) REPORTED TO CAS THAT THEY EXPERIENCED FULL AK THICKNESS DURING PROCEDURE ID # (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758595 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