FDA-Device2026-04-01Class IIPROCESSING DEFECT
AMO TECNIS Eyhance IOL recalled for potential deployment failure
What this means
AMO has recalled certain TECNIS Eyhance intraocular lenses (IOLs) used in cataract surgery because a small number may have a defect where the lens haptic (support arm) sticks to the optic, preventing proper unfolding during implantation. This affects 361 lenses distributed across 12 U.S. states. No injuries have been reported.
- If you received cataract surgery with a TECNIS Eyhance IOL, check the serial numbers on your surgical paperwork against the affected lot list
- Contact your eye surgeon immediately if your lens matches one of the recalled serial numbers
- Do not use any TECNIS Eyhance lenses with the affected serial numbers for surgery
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S Nationwide distribution in the states of CA,FL, IL, ME,MS, NJ, NY, OK, OR, TX, and WI.
Affected count
361
Manufactured in
Rd # 402 North Km 4.2, Industrial Park, Anasco, PR, United States
Products
Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY" Delivery System Model DIB00 contains the TECNISEyhance" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. Component: No
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1634-2026Want us to check the next one for you?
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