FDA DevicesClass II
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Published: March 11, 2026Recall ID: Z-1480-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Additional Source Details
| Field | Value |
|---|---|
| City | Nidau |
| State | N/A |
| Event id | 98397 |
| Address 1 | Haupt Strasse 104 |
| Address 2 | N/A |
| Code info | UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988 |
| Postal code | N/A |
| Report date | 20260311 |
| Product type | Devices |
| Product quantity | 7 |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260121 |
| Initial firm notification | N/A |
| Center classification date | 20260302 |
Overview
- Recalling FirmStaar Surgical AG
- StatusOngoing
- Risk LevelClass II
- DistributionInternational distribution to the countries of India, Iran, Korea, Saudi Arabia.