Staar Surgical AG Recalls EVO+ Visian Toric Implantable Collamer Lenses Due to Labeling Error

Source: FDA · India, Iran, Korea, Saudi Arabia

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Staar Surgical AG has issued a recall for specific EVO+ Visian Toric Implantable Collamer Lenses (TICL) that were mislabeled with the incorrect length, posing risks of ocular complications.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 2, 2026 and geographically references India, Iran, Korea, Saudi Arabia. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Staar Surgical AG has initiated a voluntary recall of seven units of its EVO+ Visian Toric Implantable Collamer Lens (TICL). The devices, intended for the correction or reduction of myopia in phakic eyes with astigmatism, were incorrectly labeled as having a length of 12.1 mm when they are actually 12.6 mm in length. This discrepancy creates a potential for "excessive vault" once the lens is implanted.

Which Products Are Affected

The recall affects the following specific medical device:

  • Product Name: EVO+ Visian Toric Implantable Collamer Lens (TICL)
  • Model Number: VTICM5
  • UDI-DI: 00840311304363
  • Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988
  • Expiration Date: 2027-11-30
  • Quantity: 7 units
  • Distribution: International distribution to India, Iran, Korea, and Saudi Arabia.

What You Should Do

Healthcare providers and facilities in the affected regions should immediately check their inventory for the serial numbers listed above. Affected units should be quarantined and not used for surgical procedures. Patients who have recently undergone implantation with this model should consult their eye care professional to monitor for symptoms of excessive vaulting or elevated eye pressure.

Why This Matters

The use of a lens with an incorrect length can lead to significant medical complications, including a reduction of irido-corneal angles, shallowing of the anterior chamber, elevated intraocular pressure (IOP), angle closure, and an unreactive pupil. In some cases, these issues may necessitate a surgical lens exchange or removal.

Source

FDA Recall Z-1480-2026

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Staar Surgical AG has issued a recall for specific EVO+ Visian Toric Implantable Collamer Lenses (TICL) that were mislabeled with the incorrect length, posing risks of ocular complications.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects India, Iran, Korea, Saudi Arabia. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.