Recall Z-1480-2026 ยท QCB Phakic Toric Intraocular Lens
Staar Surgical AG
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
| Date | Mar 2, 2026 (initiated Jan 21, 2026) |
| Status | Open, Classified |
| 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 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. |
| Root 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 Represen |
| Quantity | 7 |
| Distribution | International distribution to the countries of India, Iran, Korea, Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.