FDA recall, , Moderate risk
TECNIS Eyhance IOL with TECNIS Simplicity Delivery System
The TECNIS Eyhance IOL may have a haptic that sticks to the optic, preventing consistent unfolding.
Summary by Recall Canary from the FDA notice
What happened
AMO Puerto Rico Manufacturing, Inc., of Anasco, PR, recalled the TECNIS Eyhance IOL with TECNIS Simplicity Delivery System, Model DIB00, on February 19, 2026, because a limited quantity of the intraocular lenses may have a haptic that sticks to the optic, preventing the lens from unfolding as consistently as expected. The FDA added the recall to its Enforcement Report on March 24, 2026.
The product was distributed in California, Florida, Illinois, Maine, Mississippi, New Jersey, New York, Oklahoma, Oregon, Texas, and Wisconsin.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number matches.
TECNIS Eyhance IOL with TECNIS Simplicity Delivery System
- Model number
- DIB00
Recall details
- Company began the recall
- Sold in
U.S Nationwide distribution in the states of California,Florida, Illinois, Maine,Mississippi, New Jersey, New York, Oklahoma, Oregon, Texas, and Wisconsin.
- Company
- AMO Puerto Rico Manufacturing, Inc.Anasco, US-PR
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98402
- Recall number
- Z-1634-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
