TECNIS Eyhance IOL Recall Due to Haptic Defect
Summary
AMO Puerto Rico Manufacturing is recalling the TECNIS Eyhance IOL with TECNIS Simplicity Delivery System (Model/Catalog DIB00) due to a haptic defect where the haptic may stick to the optic, preventing consistent lens unfolding. The recall affects products distributed nationwide across 11 states including CA, FL, IL, ME, MS, NJ, NY, OK, OR, TX, and WI. This is a Class II recall initiated on April 1, 2026 and is currently ongoing.
What changed
AMO Puerto Rico Manufacturing initiated a Class II recall of TECNIS Eyhance IOL with TECNIS Simplicity Delivery System after identifying that a limited quantity of intraocular lenses may have a haptic that sticks to the optic. This defect prevents the lens from unfolding as consistently as expected during surgical procedures.
Healthcare providers, eye surgeons, hospitals, and ambulatory surgery centers that have purchased or used these intraocular lenses must immediately identify affected inventory, cease implantation of affected units, and return products per recall instructions. Patients who have already received affected lenses may experience surgical complications and should be monitored for adverse outcomes.
What to do next
- Immediately identify and quarantine all affected TECNIS Eyhance IOL units (Model DIB00) in inventory
- Cease implantation of affected lenses and notify affected surgical patients of potential complications
- Return recalled devices to AMO Puerto Rico Manufacturing per recall instructions
Penalties
Class II recall - no specific monetary penalty stated; affected devices must be removed from use
Archived snapshot
Apr 9, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
AMO Puerto Rico Manufacturing, Inc.
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1634-2026 · 20260401 · Ongoing
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 ...
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.
Source: openFDA Enforcement API
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