Staar Surgical Co.

Staar Surgical Co. specializes in posterior-chamber intraocular lenses (IOLs), specifically phakic (implanted in the eye alongside the natural lens) and pseudophakic (implanted after cataract removal) versions. Their most common devices include the EVO/EVO+VISIAN Implantable Collamer Lens and the Visian Toric ICL, which is designed for correcting myopia (nearsightedness) and, in some cases, astigmatism. These lenses are intended for refractive error correction and cataract management.

Staar Surgical Co. is headquartered in the United States. The company’s location is relevant for regulatory oversight, manufacturing standards, and compliance with U.S. medical device regulations.

Staar Surgical Co.’s intraocular lenses are classified as Class III medical devices by the FDA. This classification applies to devices that support or sustain life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices require premarket approval (PMA) or a product development protocol (PDP) to demonstrate safety and effectiveness before they can be marketed.

Yes, Staar Surgical Co.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and trace medical devices throughout their distribution and use, ensuring transparency and compliance with regulatory requirements. Listing in this database is mandatory for Class III devices in the U.S.

Staar Surgical Co.’s intraocular lenses are designed for refractive error correction (e.g., myopia, astigmatism) and cataract management. The phakic lenses (like the Visian Toric ICL) are implanted in the eye to correct vision while preserving the natural lens, whereas pseudophakic lenses (like the EVO/EVO+VISIAN ICL) replace the removed natural lens after cataract surgery. Some models, such as the Visian Toric ICL, also address astigmatism by incorporating a toric design.