FDA Class II Recall: Intraocular Lens Implants May Not Meet Specifications

Plain-English summary

Staar Surgical Company is recalling 133 units of the EVO+VISIAN Implantable Collamer Lens (model REF: VICM5_12.6), a phakic intraocular lens designed for implantation in the eye.

The FDA has classified this recall as Class II. The recalled devices may not meet manufacturing specifications, though the specific nature of the specification failure has not been detailed in the recall announcement.

The affected units were distributed to facilities across the United States, including the following states: Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.

The recalled product

Product

EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.

Manufacturer

Staar Surgical Company

Category

Medical Device — Ophthalmic / Intraocular Lens

Hazard

• specification-failure
• implant-defect

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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