Alcon Research, Ltd. recalls VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning,…

Recall date

March 1, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1394-2016

FDA classification

Class II

Brand / firm

Alcon Research, Ltd.

Sold / distributed

Worldwide Distribution - US Nationwide throughout the US and the countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Czech Republic, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, France, Georgia, Greece, Guatlemala, Hun…

Why it was recalled

Alcon is conducting a voluntary medical device correction of all VERION Reference Units (Vision Planner) that are shared with the Alcon LenSx Laser System after receiving reports concerning the inclusion of unplanned arcuates on printed, saved (.pdf) or exported surgical plans.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, imaging and guidance technology designed to provide greater accuracy and efficiency during cataract surgery. It allows eye surgeons to capture a high-resolution, diagnostic reference image of the patients eye pre-operatively, quickly determine an optimized surgical plan that enables surgeons to see all inclusions and alignment in real-time.