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FDA-Device2026-03-11Class II

EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5

Staar Surgical AG
Hazard
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.
Sold states
International distribution to the countries of India, Iran, Korea, Saudi Arabia.
Affected count
7
Manufactured in
Haupt Strasse 104, N/A, Nidau, N/A, Switzerland
Products
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1480-2026

Original summary

EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5 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. UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988 Distribution: International distribution to the countries of India, Iran, Korea, Saudi Arabia. Affected quantity: 7

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