EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | January 21, 2026 |
| Reported | March 11, 2026 |
| Recalling firm | Staar Surgical AG |
| Country / region | Switzerland N/A |
Hazard
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.
Affected products
- EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
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