Quick Facts at a Glance
- Recall Date
- February 19, 2026
- Hazard Level
- HIGH
- Brand
- AMO Puerto Rico Manufacturing
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- AMO Puerto Rico Manufacturing
- Product type
- Intraocular Lens (IOL) with Delivery System
- Model numbers
- Lot Code: GTIN: 05050474731776 SKU: DIB00U0210-12 Serial Numbers: 2409342403 2410072403 2409612403 2409692403 2409752403 2891682403 2891132403 2892032403 2531882403 2531902403 2531212403 2530842403 2531242403 2531892403 2531622403
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 19, 2026
Reported by FDA DEVICE
April 1, 2026
RecallRadar source check
April 8, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact AMO Puerto Rico Manufacturing, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
TECNIS Eyhance IOL is a single-piece, foldable posterior chamber intraocular lens used in cataract surgery. The TECNIS SIMPLICITY Delivery System is designed to deliver the lens in a sterile, touch-free manner and preloads the lens for implantation.
Why This Is Dangerous
A limited quantity of lenses may have a haptic that sticks to the optic, preventing unfolding as consistently as expected, which could impact proper lens placement.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects patients who underwent cataract surgery using this specific IOL and delivery system. Clinicians must assess each case to determine whether replacement is necessary.
Practical Guidance
How to identify if yours is affected
- Verify model number DIB00.
- Review the serial numbers listed in the recall notice to determine if your device is affected.
- Consult with your surgeon to decide on replacement options.
Where to find product info
FDA recall page and your treating ophthalmologist.
What timeline to expect
Not specified in recall. Replacement or revision is determined by clinician guidance.
If the manufacturer is unresponsive
- Escalate to the surgeon or medical device manufacturer
- File a report with the FDA if appropriate
- Keep records of all communications
How to prevent similar issues
- In future, verify device model and serial numbers before implantation
- Discuss delivery-system options with your surgeon
- Monitor for any unusual unfolding behavior during surgery
- Ensure devices come from authorized channels and verified lot numbers
Documentation advice
Keep recall notice, serial list, model number, clinician communications, and replacement plan.
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Product Details
Model/Catalog Number: DIB00. Software Version: N/A. Product: TECNIS Eyhance IOL with TECNIS Simplicity Delivery System. Distribution: U.S. nationwide in CA, FL, IL, ME, MS, NJ, NY, OK, OR, TX, WI. Quantity: 361. Sold through: healthcare providers. Lot/Serial numbers: Serial Numbers: 2409342403 2410072403 2409612403 2409692403 2409752403 2891682403 2891132403 2892032403 2531882403 2531902403 2531212403 2530842403 2531242403 2531892403 2531622403.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Serial Numbers listed in recall
- States affected: CA, FL, IL, ME, MS, NJ, NY, OK, OR, TX, WI
- Delivery System: TECNIS SIMPLICITY
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Safety Guide
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