Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

EVO+ Visian Toric Implantable Collamer Lens (TICL) Recalled by Staar Surgical AG Due to Toric Implantable Collamer for correction/reduction of myopia in...

Date: January 21, 2026
Company: Staar Surgical AG
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Staar Surgical AG directly.

Affected Products

EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5

Quantity: 7

Why Was This Recalled?

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.

Where Was This Sold?

International distribution to the countries of India, Iran, Korea, Saudi Arabia.

About Staar Surgical AG

Staar Surgical AG has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report