EVO+VISIAN Implantable Collamer Lens Recalled for Specification Failure

Plain-English summary

Staar Surgical Company is recalling 20 units of the EVO+VISIAN Implantable Collamer Lens (model REF:VICM5_12.1), a phakic intraocular lens. Each affected unit is identified by a specific serial number.

The FDA recall was issued due to a potential that the intraocular implant devices may not meet specifications. The notice does not specify which specifications are at issue or the nature of the non-compliance.

The affected lenses were distributed across multiple US states. Patients who have received this lens and their healthcare providers should verify the device serial number against the recall list to determine if their implant is affected.

Patients with an affected lens should contact their eye care provider for guidance on follow-up care. Healthcare providers should verify implant serial numbers to identify any recalled units they have implanted.

The recalled product

Product

EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.

Manufacturer

Staar Surgical Company

Category

Medical Device — Intraocular Lens

Hazard

• specification-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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