Reported Mar 11, 2026 · Ongoing
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Staar Surgical AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Staar Surgical AG · Haupt Strasse 104 · Nidau, N/A · N/A
Is this the product you have?
- EVO+ Visian Toric Implantable Collamer Lens (TICL)
- ModelVTICM5
- Lot codes and dates
- UDI-DI00840311304363
- Expiration Date2027-11-30
- Serial Numbers
T2286964T2286971T2286973T2286979T2286980T2286981T2286988
- Amount recalled
- 7
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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