Intraocular Lens Implants Recalled Due to Potential Specification Non-Compliance

Plain-English summary

Staar Surgical Company is recalling 11 EVO+VISIAN Implantable Collamer Lens devices (model VTICM5_13.2), phakic toric intraocular lenses used to correct vision. These are surgical implants placed inside the eye to correct refractive errors.

The recall was initiated because the affected devices may not meet manufacturing specifications. The FDA classified this as a Class II recall. No illnesses or injuries related to these devices have been reported.

The affected devices were distributed to healthcare facilities in 38 US 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.

Patients who received these implants should contact their surgeon to determine if their device is among the recalled units. Healthcare providers with recalled devices should follow Staar Surgical Company's instructions regarding affected products.

The recalled product

Product

EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.

Manufacturer

Staar Surgical Company

Category

Medical Device — Intraocular Lens / Ophthalmic Implant

Hazard

• specification-non-compliance

Is your product affected?

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

Distribution

Related recalls