United StatesEVO+ Visian Toric Implantable Collamer Lens (TICL), Model VTICM5 (UDI-DI 00840311304363; Exp. 2027-11-30; Serial Nos. T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988) distributed to India, Iran, Korea and Saudi Arabia is affected; lenses were labeled as 12.1 mm length but are 12.6 mm. They were recalled because the longer length can cause excessive vault and may lead to reduced irido‑corneal angles, shallowing of the anterior chamber, patient discomfort, elevated IOP/angle closure, unreactive pupil, or lens exchange/removal.
What's being recalled
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Recalling firm: Staar Surgical AG, Nidau, N/A, Switzerland.
How to identify it
UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
International distribution to the countries of India, Iran, Korea, Saudi Arabia.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada