CLASS II ONGOING Device recall · Reported 1 Apr 2026 · FDA Enforcement Report

Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System recalled

AMO Puerto Rico Manufacturing is recalling Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System, distributed nationwide in the US. The recall was initiated on 19 Feb 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: GTIN: 05050474731776 SKU: DIB00U0210-12 Serial Numbers: 2409342403 2410072403 2409612403 2409692403 2409752403 2891682403 2891132403 2892032403 2531882403 2531902403 2531212403 2530842403 2531242403 2531892403 2531622403

Quantity recalled361

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1634-2026
FDA event ID: 98402
Recalling firm: AMO Puerto Rico Manufacturing, Anasco, PR
Classification: Class II
Status: Ongoing
Recall initiated: 19 Feb 2026
FDA classified: 24 Mar 2026
Reported: 1 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Contact Lenses & Eye Devices

Timeline

19 Feb 2026	Recall initiated by company
24 Mar 2026	Classified by FDA	+33 days
1 Apr 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

U.S Nationwide distribution in the states of CA,FL, IL, ME,MS, NJ, NY, OK, OR, TX, and WI.

Nationwide California Florida Illinois Maine Mississippi New Jersey New York Oklahoma Oregon Texas Wisconsin

Questions about this recall

Is Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System recalled?

Yes. AMO Puerto Rico Manufacturing recalled Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System on 19 Feb 2026. The recall is Class II and its status is Ongoing. Recall number Z-1634-2026.

Why was it 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.

Which lots are affected?

Lot Code: GTIN: 05050474731776 SKU: DIB00U0210-12 Serial Numbers: 2409342403 2410072403 2409612403 2409692403 2409752403 2891682403 2891132403 2892032403 2531882403 2531902403 2531212403 2530842403 2531242403 2531892403 2531622403

Where was it sold?

U.S Nationwide distribution in the states of CA,FL, IL, ME,MS, NJ, NY, OK, OR, TX, and WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from AMO Puerto Rico Manufacturing

All 14

Reported	Class	Recall	Company	Reason	Where
27 Aug 2014Device	CLASS II	AMO Tecnis CL Foldable Silicone IOL with OptiEdge Design recalled	AMO Puerto Rico Manufacturing	Other	Nationwide
27 Aug 2014Device	CLASS II	AMO Tecnis CL Foldable Silicone IOL with OptiEdge Design recalled	AMO Puerto Rico Manufacturing	Other	Nationwide
27 Aug 2014Device	CLASS II	AMO Tecnis CL Foldable Silicone IOL with OptiEdge Design recalled	AMO Puerto Rico Manufacturing	Other	Nationwide
27 Aug 2014Device	CLASS II	AMO Tecnis CL Foldable Silicone IOL with OptiEdge Design recalled	AMO Puerto Rico Manufacturing	Other	Nationwide
27 Aug 2014Device	CLASS II	AMO Tecnis CL Foldable Silicone IOL with OptiEdge Design recalled	AMO Puerto Rico Manufacturing	Other	Nationwide

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