Staar Surgical AG Recalls EVO+ Visian Toric Implantable Collamer Lenses Due to Labeling Error
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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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
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
Original source: FDA Official Notice ↗
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