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Digital Fluorescence Imaging System Used in Phaco Surgery - Vietnam Registration 240003124/PCBB-HN

Access comprehensive regulatory information for Digital Fluorescence Imaging System Used in Phaco Surgery in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240003124/PCBB-HN and manufactured by WaveLight GmbH. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN ALCON PHARMACEUTICALS LTD TẠI HÀ NỘI.

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240003124/PCBB-HN
Registration Details
Vietnam MOH Registration: 240003124/PCBB-HN
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Device Details

Digital Fluorescence Imaging System Used in Phaco Surgery
VN: Hệ thống định vị bằng hình ảnh kỹ thuật số dùng trong phẫu thuật Phaco
Risk Class TBYT Loại B

Registration Details

240003124/PCBB-HN

000.00.19.H26-241014-0016

VERION™ Digital Marker M

Company Information

Technical Details

The purpose of the "VERION™ Digital Marker" is: 1. To link diagnostic and surgical information with the eye coordinate system, 2. To integrate real-time image guidance throughout the surgical and diagnostic process, 3. To provide individual patient data during the surgical process. It includes: •Planning Step: Planning the surgical steps, including the number and location of incisions, the location and size of the flap, and the meridian and axis of the IOL on the reference image. •Patient Eye Identification: Automatically checking the continuity of the reference image from the VERION™ Reference Unit or ARGOS® and the patient's eye under the microscope at the start of the surgery at the VERION™ Digital Marker. The doctor will receive feedback, whenever the reference image and the microscope image are aligned or misaligned. •Incision Guidance: The planned surgical area is overlaid on the dynamic microscope image. The lateral or rotational movements of the eye are compensated accordingly to the reference image. •Capsulotomy Guidance: The online position and radius of the capsulotomy are overlaid on the dynamic microscope image. The lateral or rotational movements of the eye are compensated accordingly to the reference image. •Alignment Guidance: The planned position of the toric IOL is overlaid on the dynamic microscope image. Lateral or rotational movements are compensated accordingly to the reference image. •Toric IOL Alignment Guidance: The online measured meridian and axis of the toric IOL are overlaid on the dynamic microscope image. The lateral or rotational movements of the eye are compensated accordingly to the reference image. •Final Review: The multi-axis and toric information is overlaid on the dynamic microscope image to review the final position of the artificial lens. The lateral or rotational movements of the eye are compensated accordingly to the reference image. •Documentation: The reference and measurement data and the surgical images are stored on an external memory. •Integrated Display Device: The integrated display device (MID) provides real-time overlaid images inside the microscope and is a part of the VERION™ Digital Marker M.

Dates and Status

Nov 15, 2024