Recall archive / FDA device enforcement
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5 — FDA record Z-1480-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 21, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
- 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.
- Classification
- Class II
- Recalling firm
- Staar Surgical AG
- Quantity
- 7
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1480-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the countries of India, Iran, Korea, Saudi Arabia.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Mar 11, 2026
- Recall initiation date
- Jan 21, 2026
- Center classification date
- Mar 2, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.