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FDAMarch 1, 2016device

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 refer...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

alcon researchalcon

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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