Recall of TECNIS Eyhance IOL with Delivery System
The FDA has announced a voluntary recall of 361 units of the TECNIS Eyhance IOL with TECNIS Simplicity Delivery System due to potential issues with the lens unfolding.
Recall of TECNIS Eyhance IOL with Delivery System
What Happened
AMO Puerto Rico Manufacturing, Inc. is recalling the TECNIS Eyhance IOL with TECNIS Simplicity Delivery System because a limited quantity of intraocular lenses may have a haptic that sticks to the optic, preventing the lens from unfolding as consistently as expected.
Which Products Are Affected
The affected product is the TECNIS Eyhance IOL with TECNIS Simplicity Delivery System, Model/Catalog Number: DIB00. Approximately 361 units are involved, with distribution in the U.S. states of CA, FL, IL, ME, MS, NJ, NY, OK, OR, TX, and WI. Specific codes include Lot Code: GTIN: 05050474731776, SKU: DIB00U0210-12, and Serial Numbers: 2409342403, 2410072403, 2409612403, 2409692403, 2409752403, 2891682403, 2891132403, 2892032403, 2531882403, 2531902403, 2531212403, 2530842403, 2531242403, 2531892403, and 2531622403. The official recall number is Z-1634-2026.
What You Should Do
Consumers should follow the initial firm notification, which was sent via letter, and contact AMO Puerto Rico Manufacturing, Inc. at their address: Rd # 402 North Km 4.2, Industrial Park, Anasco, PR 00610, for instructions on returns or refunds.
Why This Matters
This recall involves medical devices used in eye surgery, which could lead to inconsistent performance and potential complications for patients if not addressed.
Source
FDA Recall Number: Z-1634-2026. For more information, visit the FDA website.
Source: FDA Official Notice