[pending] EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Pending LLM rewrite. Source: FDA_DEVICE Z-1480-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
- Manufacturer
- Staar Surgical AG
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964
- T2286971
- T2286973
- T2286979
- T2286980
- T2286981
- T2286988
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- ModeratePhilips Allura X-ray Systems Deaeration Hose Degradation Recall
FDA (Devices) · 2026-05-27
- HighOncology Kit With Extension Sets May Leak During Infusion Therapy
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula vascular catheter sterile barrier breach
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27