AMO Puerto Rico Manufacturing, Inc. recalls Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECN

Recalling company

AMO Puerto Rico Manufacturing, Inc.

Product

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

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Feb 19, 2026

Reported

Apr 1, 2026

Distribution

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

Status

Ongoing

Quantity

361

Lot / codes

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

Company location

Anasco, PR

Recall type

Voluntary: Firm initiated

Recall number

Z-1634-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1634-2026 in the FDA Enforcement Report. Also see FDA recall press releases.