Official recall record
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2026-01-21
- Country of alert
- Switzerland
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00840311304363
- Brand on record
- Staar Surgical AG
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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