Reported Apr 1, 2026 · Ongoing
Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS…
AMO Puerto Rico Manufacturing, Inc.
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: AMO Puerto Rico Manufacturing, Inc. · Rd # 402 North Km 4.2, Industrial Park · Anasco, PR · 00610
Is this the product you have?
- Brand NameTECNIS Eyhance IOL with TECNIS Simplicity"
- Delivery System Product NameTECNIS Eyhance IOL with TECNIS Simplicity"
- Delivery System Model/Catalog NumberDIB00
- Software VersionN/A
- Product DescriptionThe 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
- ComponentNo
- Lot codes and dates
- Lot CodeGTIN: 05050474731776
- SKUDIB00U0210-12
- Serial Numbers
240934240324100724032409612403240969240324097524032891682403289113240328920324032531882403253190240325312124032530842403253124240325318924032531622403
- Amount recalled
- 361
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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