Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance
- Recall date
- 2026-04-01
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.
Recommended action
What to do
361
Product description
Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.