Alcon Research LLC 2024-07-24 Health serious FDA
Health · FDA · Recall #FDA-Z-2412-2024
Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization… Recall
Issued July 24, 2024 · Alcon Research LLC
In July 2024, Alcon Research LLC recalled the Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect new registration angle, range indicator will display incorrectly, which could result in incorrect placement of toric IOL axis, which could cause astigmatic error under/over correction resulting in decreased uncorrected visual acuity.
What you should do
- 1 Stop using Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Alcon Research LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Alcon Research LLC
- Category
- Health
- Recall date
- July 24, 2024
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution including in the states of AL, AR, CA, CO, CT, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO
- Recall number
- FDA-Z-2412-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Alcon Research LLC has 12 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.