TECNIS Eyhance IOL with Simplicity Delivery System Recall: Haptic May Stick to Optic

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Contact the company & request your remedy

Recalling firmAMO Puerto Rico Manufacturing, Inc.Rd # 402 North Km 4.2, Industrial Park · Anasco, PR 00610

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✎ GovInfoNow plain-language explainer

What happened, in plain English

AMO recalls TECNIS Eyhance IOLs with Simplicity Delivery System (model DIB00) because a limited number of lenses may have a haptic that sticks to the optic, preventing consistent unfolding. This could lead to improper lens placement in the eye.

Why it’s dangerous

The haptic (a small part of the lens) may stick to the optic (the main lens part) during insertion. This can prevent the lens from unfolding properly, potentially causing improper placement in the eye.

Who’s affected

Patients who received the TECNIS Eyhance IOL with Simplicity Delivery System model DIB00 (serial numbers listed) are affected. Those with the specific serial numbers are most at risk.

How to tell if you have this one

Check for the model DIB00 with serial numbers listed in the recall notice. The product includes the TECNIS Eyhance IOL with Simplicity Delivery System.

Brand
TECNIS
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Serial Numbers
Look for serial numbers on the packaging or product label: 2409342403, 2410072403, 2409612403, 2409692403, 2409752403, 2891682403, 2891132403, 2892032403, 2531882403, 2531902403, 2531212403, 2530842403, 2531242403, 2531892403, 2531622403.

✎ GovInfoNow

Questions people ask

Is this recall affecting all TECNIS Eyhance IOLs?

No, only the specific model DIB00 with the listed serial numbers.

What should I do if I have the recalled product?

Check the product serial numbers against the list provided in the recall notice.

Is there a fix for this issue?

The recall notice does not mention a remedy or fix.

Take action

Contact TECNIS

We’ve drafted a message you can send TECNIS to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1634-2026 — TECNIS TECNIS

Hello,

I own a TECNIS that is covered by recall Z-1634-2026 from TECNIS.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1634-2026 (February 19, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1634-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

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

Lower-risk recall