What STAAR Surgical Company told the SEC could break it.

Two customers — STAAR's China distributors selling into China and Hong Kong — accounted for ~32% of consolidated net sales in fiscal 2025 ($77.8M), down sharply from 51.7% in 2024 and 57.2% in 2023, reflecting both a heavy single-market concentration and a steep recent decline in China demand. The distributors are not individually named.

“Two customers, our China distributors who sell into China and Hong Kong, accounted for approximately 32% of our consolidated net sales during fiscal 2025.”

STAAR's largest market is China; U.S.–China tariffs and trade tensions (e.g., the February 1, 2025 U.S. tariffs of 25% on Mexico/Canada and 10% on China, and China's counter-tariffs, with a one-year suspension agreement expiring November 10, 2026) could depress China economic conditions and STAAR's sales and operations in the region.

“The institution of trade tariffs both globally and between the U.S. and China specifically could negatively impact the overall economic condition in our markets, including China, which could have a negative effect on our sales. As an example, on February 1, 2025, the U.S. government announced a 25% tariff on product imports from certain countries, including Mexico and Canada, and 10% tariffs on product imports from certain countries, including China.”

Some of the raw materials and components STAAR uses to manufacture its implantable Collamer lenses (ICLs) are single-sourced due to regulatory constraints, cost effectiveness, availability, quality, and vendor reliability; loss of a material supplier could significantly disrupt the business.

“STAAR uses a wide range of raw materials in the production of our ICLs. STAAR purchases most of the raw materials and components from external suppliers. Some of our raw materials are single-sourced due to regulatory constraints, cost effectiveness, availability, quality, and vendor reliability issues.”