Staar Surgical AG recalls EVO+ Visian Toric Implantable Collamer Lens (TICL)

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.

On 1/21/2026, a Field Safety Notice was mailed to customers who were asked to do the following: 1. If any of the devices identified in the Field Safety Notice Return Response form have not already been implanted, remove them from your inventory and quarantine the product. 2. Complete the Field Safety Notice Return Response form indicating if each device has been implanted or is in your possession. 3. Complete and email the Field Safety Notice Return Response form to customerservice.ag@staar.com. 5. Return affected devices to the firm. Should you have any questions, contact the firm's Representative or Customer Service at customerservice.ag@staar.com or by phone at +41323328888 Monday through Friday, 8:00am to 5:00pm CET.

• FDA enforcement recordOfficial FDA database entry for Z-1480-2026
• FDA device classification · QCBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 886.3600The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Staar Surgical AGSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.