Alcon Research, Ltd. Recall: VERION Reference Unit (Vision Planner) Product Usage: The VER
Alcon Research, Ltd. Recall: VERION Reference Unit (Vision Planner) Product Usage: The VER is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Alcon Research, Ltd.; Product: VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical plannin
| Recalling firm | Alcon Research, Ltd. |
|---|---|
| Product | 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. |
| Reason for recall | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | 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, Hung |
| Recall initiated | 20160301 |
| Recall number | Z-1394-2016 |
| Category | device |
| State | TX |
| Country | United States |
$29/mo
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