# FDA recall Z-1634-2026

> **AMO Puerto Rico Manufacturing, Inc.** · Class II · device recall initiated 2026-02-19.

## 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 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1634-2026
- **Recalling firm:** AMO Puerto Rico Manufacturing, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-19
- **Report date:** 2026-04-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Anasco, PR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1634-2026

## Citation

> AI Analytics. FDA recall Z-1634-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1634-2026. Source: US FDA. Licensed CC0.

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