Summary
The FDA issued a Class II for EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5 by Staar Surgical AG. Reason: 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 le.
Details
Source
Device Recall
External ID
Z-1480-2026
Action Date
2026-03-11
Status
Ongoing
Category
device
Product Description
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Lot/Code Info: UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988
Quantity Affected: 7
Reason for Recall
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.
Distribution
International distribution to the countries of India, Iran, Korea, Saudi Arabia.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-21
Company
Nidau, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 133 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Staar Surgical AG has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Staar Surgical AG) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Staar Surgical AG have FDA actions?
Staar Surgical AG has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1480-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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