CLASS II ONGOING Device recall · Reported 11 Mar 2026 · FDA Enforcement Report

EVO+ Visian Toric Implantable Collamer Lens (TICL) recalled

Staar Surgical AG is recalling EVO+ Visian Toric Implantable Collamer Lens (TICL), distributed nationwide in the US. The recall was initiated on 21 Jan 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988

Quantity recalled7

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1480-2026
FDA event ID: 98397
Recalling firm: Staar Surgical AG, Nidau, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 21 Jan 2026
FDA classified: 2 Mar 2026
Reported: 11 Mar 2026
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

21 Jan 2026	Recall initiated by company
2 Mar 2026	Classified by FDA	+40 days
11 Mar 2026	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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

Where it was distributed

International distribution to the countries of India, Iran, Korea, Saudi Arabia.

Nationwide

Questions about this recall

Is EVO+ Visian Toric Implantable Collamer Lens (TICL) recalled?

Yes. Staar Surgical AG recalled EVO+ Visian Toric Implantable Collamer Lens (TICL) on 21 Jan 2026. The recall is Class II and its status is Ongoing. Recall number Z-1480-2026.

Why was it recalled?

Which lots are affected?

UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988

Where was it sold?

International distribution to the countries of India, Iran, Korea, Saudi Arabia.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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