Class 2 Device Recall EVO Visian Toric Implantable Collamer Lens (TICL)

• Date Initiated by Firm: January 21, 2026
• Date Posted: March 02, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1480-2026
• Recall Event ID: 98397
• PMA Number: P030016
• Product Classification: Phakic toric intraocular lens - Product Code QCB
• Product: EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
• Code Information: UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988
• FEI Number: 3002808259
• Recalling Firm/ Manufacturer: Staar Surgical AG; Haupt Strasse 104; Nidau Switzerland
• For Additional Information Contact: Philip Tsung; 626-3037902 Ext. 2263
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: 7
• Distribution: International distribution to the countries of India, Iran, Korea, Saudi Arabia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = QCB