Reported Apr 20, 2016 · Terminated
VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning,…
Alcon Research, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alcon Research, Ltd. · 6201 South Fwy · Fort Worth, TX · 76134-2099
Is this the product you have?
- VERION Reference
- Unit (Vision Planner) Product UsageThe 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
- Lot codes and dates
- Serial Numbers
97 of 97 codes
101711191123112511261128113311351136113711381139114211471150115311551161116511681172117811811182118311881190119111931196119711981199120112031206120712201226122812301232125012561258125914211433143514391451145215061508150915231536154815591562
- Serial Numbers
- Amount recalled
- 97 units
Where it was sold
- Nationwide
- GA
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Alcon Research, Ltd. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.