Notice of Intent to Award Sole Source Food and Drug Administration (FDA) approved EVO Toric Lenses and EVO Lenses

The U.S. Department of Defense, through the Medical Readiness Contracting Office – West at Fort Hood, Texas, intends to award a sole-source, firm-fixed-price purchase order to STARR Surgical Company for FDA-approved EVO Toric Lenses and EVO Spherical Intraocular Collamer Lenses, along with associated MICROSTAAR Injection Systems and LILI INJ devices, to support surgical vision correction for military personnel at Carl R. Darnall Army Medical Center. This acquisition, justified under FAR 12.102(b), is non-competitive due to the exclusive nature of STAAR Surgical’s proprietary Collamer material and the unique regulatory and technical specifications required for mission-critical vision correction in high-risk operational environments. Market research confirmed no other manufacturers, including small businesses, can meet the required FDA standards, lens configurations, or material composition, rendering STARR Surgical the only viable source. The contract will have a five-year period of performance from October 1, 2026, through September 30, 2031, including one base year and four one-year option periods, with delivery and performance occurring at Fort Hood, Texas. All products must be FDA-approved, and implanting surgeons must be certified through the STAAR Surgical Vision TICL Physician Certification Program. No competition, evaluations, or pricing details are solicited, and the award is based solely on technical necessity, not cost or trade-off analysis. No formal contract clauses, evaluation factors, inspection criteria beyond FDA approval, or detailed packaging, labeling, or preservation standards are specified. The procurement relies on the uniqueness of the Collamer-based lenses, confirmed by market analysis through DMLSS, ECAT, and FSS systems, and the absence of alternative suppliers within the NAICS code 339113 with a size standard of 800 employees. STARR Surgical Company, located in Lake Forest, California, is the sole identified provider; its size status is determined as other than small, and no socioeconomic certifications are claimed. Funding is sourced from the Fiscal Year Defense Health Program under 41 U.S.C. §1901, with no subcontracting permitted and no subcontracting plan required. The contract will be awarded on or about June 12, 2026, following a notice issued on May 26, 2026, with a response deadline of June 4, 2026, though no competitive proposals are being requested. No payment office