P03 JOFOC_Redacted.pdf

JUSTIFICATION AND APPROVAL (J&A)

For Other Than Full and Open Competition Authority: VAAR 819.7008 (SDVOSB Sole Source) and FAR 6.302-5(c)(2)(ii) Requirement: Alcon LenSx Femtosecond Laser System (Brand Name) Awardee: Verified SDVOSB) Prepared by: Department of Veterans Affairs (VA), North Texas Veterans Health Care System, NCO 17

JOFOC: FY26 - NCO 17 - 2444

Date: September 20, 2026

1. Agency and Contracting Activity

This action is by the Department of Veterans Affairs, Veterans Health Administration (VHA), North Texas Veterans Health Care System (NTVHCS), Network Contracting Office (NCO) 17. The VA Veterans First Contracting Program prioritizes SDVOSB/VOSB awards in accordance with VAAR Subpart 819.70.

2. Nature and Description of the Action Being Approved

Approval is requested to award a sole-source contract to a VIP-listed Service-Disabled Veteran-Owned Small Business (SDVOSB), for the purchase, delivery, installation, verification testing, OEM-authorized training, and warranty/service support of one Alcon LenSx Femtosecond Laser System (including required accessories and consumables) for NTVHCS Ophthalmology. The anticipated award will be firm-fixed-price, total value not to exceed $5,000,000 (inclusive of options), as required by VAAR 819.7008(a)(1). The total Estimated contract value is

3. Description of Supplies/Services

The LenSx is an FDA-cleared femtosecond laser platform for anterior capsulotomy, corneal incisions, and lens fragmentation used during cataract surgery. The system provides OCT-guided planning, OnAxis astigmatism management, permanent capsular toric marks, multiple fragmentation patterns (e.g., star/cross/horizontal), and the SoftFit hydrogel patient interface designed to reduce capsular tear risk—all supported by a large evidence base and usage across 4.5+ million procedures. Deliverables include the laser console, installation/acceptance testing, OEM training, user manuals, disposables, and full manufacturer warranty.

4. Statutory Authority Permitting Other Than Full and Open Competition

This acquisition will be conducted under VAAR 819.7008 (SDVOSB sole source) and FAR 6.302-5(c)(2)(ii) (“Authorized or required by statute”). VAAR 819.7008 permits a CO to award a sole-source contract to a VIP-listed SDVOSB when: (1) anticipated award price (including options) does not exceed $5,000,000; (2) the requirement is synopsized and the justification posted per FAR part 5; (3) the SDVOSB is responsible;

and (4) award can be made at a fair and reasonable price. Contracts under this authority must be supported by a written J&A per FAR 6.303 and 6.304.

Posting & Compliance: The requirement will be synopsized and the J&A posted in accordance with FAR 6.302-5(c)(2)(ii) and FAR 6.305.

5. Rationale: Proprietary Technical Requirements & Unique Qualifications (Brand-Name Basis)

The Government’s minimum needs require Alcon LenSx due to OEM-controlled, proprietary features and integrations that are essential for clinical safety, workflow continuity, and interoperability at - OCT-Integrated OnAxis Astigmatism Guidance with Permanent Capsular Toric Marks. LenSx provides femtosecond-assisted capsular toric marking; these permanent marks enable precise toric IOL alignment and rotational stability verification post-surgery—capabilities defined in Alcon’s professional documentation for LenSx.

• OEM Ecosystem Interoperability. LenSx connects to ARGOS® Biometer and VERION Image Guided System, ensuring end-to-end planning and astigmatism management consistent with surgeon workflows and existing Alcon equipment at VA facilities. This interoperability is proprietary to Alcon’s ecosystem, supporting consistent outcomes and minimizing integration risk.

• SoftFit Hydrogel Patient Interface. LenSx’s SoftFit interface is engineered to reduce corneal compression during docking; documentation cites <0.1% capsular tear rate with the SoftFit interface—meeting [Facility’s] safety requirements for Veteran patients.

• Proven Clinical Utilization and Efficiency. LenSx features multiple fragmentation patterns tailored to lens density and has demonstrated per-patient OR time reductions vs conventional approaches (e.g., RCT/time-and-motion studies), supporting throughput goals without compromising outcomes.

These proprietary capabilities are integrated into Alcon’s technology architecture and cannot be replicated via generic or alternate platforms without materially altering surgeon workflows, image guidance links, and safety interfaces central to [Facility]’s standard of care.

6. Why Competitors Are Unable to Meet the Government’s Need

Market research reviewed alternative femtosecond platforms (e.g., , and others) and determined that none offers the same proprietary combination of OCT-guided OnAxis marking, permanent capsular toric references, SoftFit hydrogel interface, and Alcon ecosystem connectivity (ARGOS/VERION) necessary for NTVHCS’s standardized workflow and safety profile. Alternatives would not match the required interoperability and would necessitate significant retraining, workflow redesign, and risk management.

Clinical Differentiation Note: Peer-reviewed literature comparing femtosecond platforms (e.g., low- vs high-energy systems) shows differing tissue effects (e.g., miosis, subconjunctival hemorrhage), underscoring that platform choice has material safety implications. While such studies (e.g., LenSx vs Z8) inform risk profiles, NTVHCS’s minimum needs are anchored in LenSx’s proprietary imaging/marking ecosystem and interface technology.

7. Efforts to Obtain Competition

The Contracting Officer conducted a review of VA market activity and the landscape of

OEM-authorized resellers. Recent VA solicitation 36C25726Q0903 referenced “LenSx brand name or equal,” indicating broad market awareness of the requirement. During the solicitation phase, proprietary technical needs were identified that can only be met through the LenSx system. Concurrent with that discovery, the solicitation was canceled due to revised specifications and technical clarifications that could not be accommodated under the existing solicitation framework, in accordance with FAR

14.404-1(c)(1) (inadequate or ambiguous specifications). Therefore, this procurement will be awarded solely to an SDVOSB under VAAR 819.7008, in alignment with

Veterans First priorities and the Government’s confirmed brand-name requirement.

CO Discretion: Under 819.7008(b), the decision to make an SDVOSB sole-source award is discretionary and used only when in the Government’s best interest; no determination that only one SDVOSB can meet the requirement is required under 819.7008(c), though a written J&A is mandatory.

8. Awardee Eligibility and Responsibility is a VIP-listed SDVOSB and will be verified by the CO for eligibility under VAAR 819.7003 prior to award. The CO will also confirm OEM authorization to sell, install, and service the LenSx platform and confirm TAA compliance for the end product.

9. Determination of Fair and Reasonable Price

The CO will establish price reasonableness using: (a) OEM catalog/list and discount analysis; (b) comparison to recent VA LenSx® procurements; (c) negotiations on installation, training, warranty, and consumables; and (d) an Independent Government Estimate (IGE). This determination satisfies VAAR 819.7008(a)(4) and FAR 6.303-2 documentation requirements.

10. Description of Market Research

The requiring activity reviewed OEM technical materials and VA posting history for similar systems (e.g., NCO-17 solicitations citing LenSx brand name or equal). Findings support that LenSx uniquely aligns with VA’s established surgical ecosystem and surgeon training/credentialing.

11. Other Facts Supporting Use of Sole Source

• Threshold Compliance: The total value (including options) will not exceed $5,000,000; the requirement will not be split to avoid threshold limits.

• Posting & Synopsis: The requirement and J&A will be posted as required by FAR part 5 and FAR 6.302-5(c)(2)(ii)/6.305.

• Veterans First: The award to a verified SDVOSB is consistent with VA’s Veterans First Contracting Program (38 U.S.C. § 8128)

12. Actions to Promote Future Competition

The requiring activity will (a) annually assess alternative platforms’ interoperability with the installed ecosystem; and (b) continue market research on evolving femtosecond technologies.

13. Technical/Requirements Certification

I certify that the LenSx brand-name specifications, including OnAxis toric marking, SoftFit interface, and ARGOS/VERION connectivity, represent the minimum needs of the government and NTVHCS and are necessary to ensure patient safety, workflow continuity, and integration with existing VA surgical systems.

14. Contracting Officer Certification

I certify this J&A is accurate and complete, and that award to under VAAR 819.7008 is in the best interest of the Government, satisfies Veterans

First priorities, and will be posted consistent with FAR 6.305.