20

Apr

2016

Cl II Alcon VERION Reference Unit

0

Company: Alcon Research, Ltd.
Date of Enforcement Report 4/20/2016
Class lI:

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 patient s eye pre-operatively, quickly determine an optimized surgical plan that enables surgeons to see all inclusions and alignment in real-time.
Recall Number Z-1394-2016

REASON
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..

RECALLING FIRM/MANUFACTURER
Alcon Research, Ltd., Fort Worth, TX on 3/12016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
97 units

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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