Quick Facts at a Glance
- Recall Date
- January 21, 2026
- Hazard Level
- HIGH
- Brand
- STAAR Surgical AG
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- STAAR Surgical AG
- Product type
- Toric Implantable Collamer Lens (TICL)
- Model numbers
- VTICM5, UDI-DI: 00840311304363, Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988
- Sizes
- 12.6 mm length (actual), 12.1 mm (labeled)
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 21, 2026
Reported by FDA DEVICE
March 11, 2026
RecallRadar source check
March 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may cause: Significant reduction of irido-corneal angles, Significant shallowing of anterior chamber, Patient discomfort, Elevated IOP/Angle closure, Unreactive pupil, Lens exchange/removal.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Staar Surgical AG or your healthcare provider for instructions. Notification method: N/A
About This Product
The EVO+ Visian TICL is a toric implantable lens used to correct myopia with astigmatism in phakic eyes. It is implanted by an ophthalmic surgeon during a cataract or refractive procedure in appropriate candidates.
Why This Is Dangerous
A length labeling error caused the device to be longer than labeled. This can create excessive vault, leading to eyes issues and possibly requiring surgical intervention.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients may require lens exchange or removal. Urgent ophthalmologic follow-up is advised for implanted patients and people awaiting implantation.
Practical Guidance
How to identify if yours is affected
- Identify if your device is VTICM5 with serial numbers listed above.
- Check the UDI-DI 00840311304363 on packaging or documentation.
- Review the recall notice from the FDA for the enforcement number Z-1480-2026.
Where to find product info
UDI-DI and serial numbers are printed on labeling and packaging; patient records will include implant details.
What timeline to expect
4-8 weeks for replacement or removal arrangements in many regions; actual surgical timelines vary by provider.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer.
- Escalate to the surgeon and local health authorities if needed.
- Consider filing a complaint with the appropriate regulatory body.
How to prevent similar issues
- Verify device length labeling before implantation
- Ensure implant labeling matches the actual device dimensions
- Work with accredited ophthalmology centers with established recall protocols
Documentation advice
Keep recall notices, surgical records, serial numbers, and communications with providers and manufacturers.
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Product Details
Brand: STAAR Surgical AG Product: EVO+ Visian Toric Implantable Collamer Lens (TICL) Model: VTICM5 UDI-DI: 00840311304363 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988 Expiration Date: 2027-11-30 Quantity Recalled: 7 units Recall Date: 2026-01-21 Distributor Regions: India, Iran, Korea, Saudi Arabia Sold at: Unknown Manufacturer: STAAR Surgical AG
Key Facts
- Countries affected: India, Iran, Korea, Saudi Arabia
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Safety Guide
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