FDA Device recall Z-1480-2026
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
- FDA Device
- Class II
- ongoing
- Published 2026-03-11
On 2026-03-11 the FDA classified a Class II recall of EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5 by Staar Surgical Ag, citing 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 potenti….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1480-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-21 |
| Published | 2026-03-11 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Staar Surgical Ag |
| Distribution | n/a |
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.
Identifiers
| code_info | UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1480-2026%22
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