EVO+ Visian Toric Implantable Collamer Lens — Class II medical device recall Z-1480-2026
Ongoing recall by Staar Surgical AG, reported 2026-03-11. Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as
| Recall number | Z-1480-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Staar Surgical AG, Nidau, N/A, Switzerland |
| Recall initiated | 2026-01-21 |
| Classified | 2026-03-02 |
| Reported by FDA | 2026-03-11 |
| Countries outside the US | IN, IR, KR, SA |
| Quantity | 7 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00840311304363 |
| Serial numbers | T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988 |
| Model numbers | VTICM5 |
| Expiration dates | 2027-11-30 |
Product
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1480-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.