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

FDA device recall Z-1480-2026 · posted 2026-03-02 · Open, Classified

Recall details

Recalling firm

Staar Surgical AG

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.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

QCB

Quantity affected

7

Distribution

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

Date initiated

2026-01-21

Date posted

2026-03-02

Location

Nidau, Switzerland