Justification RFO FAR 12.102(b) SURGICAL LENSES REDACT.pdf

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Control Number: 26-MRCO-W-111

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CUI//PROCURE JUNE 2025

Controlled by: USAHCA Controlled by: MRCO-W Limited Dissemination Control: FEDCON POC: Bobby Etheridge, bobby.j.etheridge.civ@health.mil

JUSTIFICATION REVIEW DOCUMENT

RFO FAR 12.102(b), Restricting Competition for Acquisitions Valued Over the

Simplified Acquisition Threshold

Program/Equipment: Carl R. Darnall Army Medical Center (CRDAMC) requires the purchase of Food and Drug Administration (FDA) approved EVO Toric Lenses and EVO Lenses. The intraocular Collamer lenses (ICL) implants that are required during surgical procedures for soldiers with extreme refractive error, and who have very poor visual function without glasses.

Authority: Title 41 United States Code (U.S.C.) §1901 as implemented in RFO FAR 12.102(b), restricting competition for acquisitions valued over the simplified acquisition threshold.

Amount: $1.6 Million

Prepared by: Bobby Etheridge Phone: (254) 288-4769 Contract Specialist Date:

E-mail: bobby.j.etheridge.civ@health.mil

Contracting Officer: Joshua P. Barbero Phone: (254) 553-3909

Contracting Officer Date:

E-mail: joshua.p.barbero.civ@health.mil

Technical: Laura A. Ballou Phone: (254) 553-3668

Deputy Operative Services Director Date:

E-mail: laura.a.ballou.civ@health.mil

Requirements: Valarie Lawyer-Jefferson Phone: (254) 288-8793

Contracting Officer Representative Date:

E-mail:

Reviews: I have reviewed this justification and find it adequate to support other than full and open competition.

Legal Counsel:

Frank Yoon Phone: (703) 681-4357/ DSN: 681-4357 Associate General Counsel E-mail: frank.yoon.civ@health.mil mailto:bobby.j.etheridge.civ@health.mil mailto:bobby.j.etheridge.civ@health.mil mailto:joshua.p.barbero.civ@health.mil mailto:laura.a.ballou.civ@health.mil mailto:frank.yoon.civ@health.mil

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RFO FAR 12.102(b), Restricting Competition for Acquisitions Valued Over the Simplified Acquisition Threshold

1. Requiring Activity: Ophthalmology Department Carl R. Darnall Army Medical Center (CRDAMC) Fort Hood, Texas.

2. Contracting Activity: Medical Readiness Contracting Office – West (MRCO-W), Fort Hood, Texas.

3. Description of Action: Request approval to award a successive follow-on noncompetitive five-year (base and four one-year options) firm-fixed price contract with STARR Surgical Company. The contract will be funded using appropriate Fiscal Year Defense Health Program (DHP) funds.

STARR Surgical Company 25651 Atlantic Ocean Dr. STE A1 Lake Forest, CA 92630 Cage: 04LD1

SAM UEID: LTCEBJ8NUZJ4

4. Description of Supplies/Services: CRDAMC Ophthalmology requires the procurement of EVO Spherical Lenses and EVO Toric Lenses along with MICROSTAAR Injection System MSI-PF (3 pk) Part Number 37000052, MICROSTAAR Injection System MSI-PF (10 pk) Part Number 37000054, and LILI INJ (10 pk) Part Number 37000028. Surgical Intraocular Collamer Lenses (ICL) are used in refractive surgery.

Period Period of Performance (POP) Estimated Value

Base Period 1 Oct 26 - 30 Sep 27 $299,670.00 Option Year #1 1 Oct 27 - 30 Sep 28 $314,654.00 Option Year #2 1 Oct 28 - 30 Sep 29 $330,386.00 Option Year #3 1 Oct 29 - 30 Sep 30 $346,905.00 Option Year #4 1 Oct 30 - 30 Sep 31 $364,251.00

Estimated Total Price $1,655,866.00

5. Authority Cited: Title 41 U.S.C. 1901, as implemented by RFO Federal Acquisition Regulation (FAR) 12.102(b), restricting competition for acquisitions valued over the simplified acquisition threshold.

Reason for Authority Cited: Soldiers with extreme refractive error who have very poor visual function without glasses and are not candidates for PRK or LASIK procedures require intraocular surgical implants. There are several FDA approved products. From a

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mission-readiness perspective, Collamer lenses are often utilized by service members who require high-performance vision in diverse environments (night operations, high altitude, etc.) where contact lenses or glasses might be a liability. STAAR Surgical lenses are intraocular Collamer lenses (ICL) implants that are required during surgical procedures. Collamer is a proprietary, biocompatible material used exclusively by STAAR Surgical in the manufacturing of their Implantable Collamer Lenses. The name itself is a portmanteau of "Collagen" and "Polymer," reflecting its unique chemical composition.

a. Background: All physicians must complete the STARR Surgical Vision TICL Physician Certification Program prior to use.

b. Alternatives: Currently, there are no other vendors that can meet the

Government’s requirements. The Government requires the contractor must be approved by the FDA and lenses must be available/made from Collamer.

c. Impact if not approved: Failure to approve the justification could lead to soldiers that are not candidates for PRK or LASIK not being combat ready due to changes in vision and will have to rely on glasses or contact lenses which introduce significant risks to operational and combat safety.

6. Efforts to Obtain Competition: A sources sought was posted to SAM.gov from 01 April 2026 through 07 April 2026. On 03 April 2026, contracting received an email from BHPE LLC's stating they were interested, but when asked for their proof of FDA approved lenses/capabilities statement they were unable to provide any information.

a. Effective competition: STARR Surgical is the sole manufacturer and distributor. The reference letter was received on 31 March 2026 and uploaded to PCF. Competition is not anticipated due to no other known sources who can meet all the Government’s minimum requirements.

b. Subcontracting competition: There are no anticipated subcontracting opportunities in accordance with (IAW) FAR 19.109.

7. Actions to Increase Competition: This action is a follow-on to contract W81K00- 22-P-0203 under the previous Justification and Approval (Control No. 23-RHCO-C-22), located in PCF.

The Requiring Activity (RA) conducted market research using Medical Electronic Catalog (ECAT) and Defense Medical Logistics Standard Support (DMLSS) and other market research techniques to confirm if there were any other lenses that could meet the organizational needs.

Defense Logistics Agency (DLA) Medical Electronic Catalog (ECAT) and Medical Master Catalog (MMC) – ECAT do have surgical lenses, but all the required sizes are not available for purchase and not made from Collamer and do not meet the

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specifications in the performance requirements.

The Defense Medical Logistics Standard Support (DMLSS) Automated Information System (AIS) Market research results there are other surgical lenses, but all the required sizes are not available for purchase and not are made from Collamer and do not meet the specifications in the Performance Requirements.

8. Market Research: Market research was conducted in accordance with FAR Part 10.

A search of the Small Business Administration’s (SBA) Dynamic Small Business Search (DSBS) using NAICS 339113-Surgical Appliance and Supplies Manufacturing and using keywords “Surgical Lenses” found that zero (0) small businesses can provide these services. A further review of economic groups under this NAICS is found in Table 1, DSBS Summary.

TABLE 1: DSBS Summary

Economic Group Number of Firms Veterans 0 Service-Disabled Veterans 0 Currently 8(a) Certified 0 Currently HubZone Certified 0 Currently SDB Certified 0 Woman or Women Owned 0

A search of the Federal Supply Schedule (FSS) was conducted using “Intraocular Collamer Lenses” as the keywords. Table 2 is a summary of the search, which identified there are not any possible applicable category Intraocular Collamer Lenses. A total of zero FSS/VA contractors were found to provide these supplies.

TABLE 2: FSS/VA Schedule Review Summary

Contractor FSS/VA Number Schedule Expiration Date N/A N/A N/A

A search of National Health Institute, USAspending.gov, fpds.gov, and vendorportal.ecms.va.gov in combination with open market, previous awarded contract research was conducted using “Intraocular Collamer Lenses” as the keywords. Table 3 is a summary of the search.

TABLE 3: Online Summary of Findings

ITEM

INFORMATION

SOURCE 1 SOURCE 2 SOURCE 3

Source STAAR Surgical CO None None

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Specific Item IMPLANTABLE COLLAMER LENSES (ICL) None None

9. Interested Sources: A sources sought was posted to SAM.gov from 01 April 2026 through 07 April 2026. On 03 April 2026 BHPE LLC's stated they were interested, but when asked for their proof of FDA approved lenses/capabilities statement they were unable to provide any information.

10. Other Facts:

a. Procurement history. This is a successive, sole source follow-on requirement to the contracts below:

Contract Number /

Contractor Contract

Type Procurement

Method Offerors/ Bidders/ Vendors

Amount Period of Performance

W81K00-22-P-0203 / Staar Surgical CO

FFP Sole Source 1 $2,994,855.00 01 OCT 2022 –

30 SEP 2026

W81K00-20-P-0349 / Staar Surgical CO

FFP Sole Source 1 $240,000.00 01 OCT 2020 –

30 SEP 2022

1) Contract numbers and dates of all contracts awarded for these same requirements.

a. W81K00-22-P-0203 awarded on 10 August 2022.

b. W81K00-20-P-0349 awarded on 29 December 2017.

2) The competitive status of these actions.

a. W81K00-22-P-0203 Only one source.

b. W81K00-20-P-0349 Competed under SAP.

3) Authority previously cited if less than full and open competition was used.

Title 41 United States Code (U.S.C.) §1901(e)(2) as implemented in Federal Acquisition Regulation (FAR) 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

4) If any prior contract for this requirement was accomplished using full and open competition or full and open competition after exclusion of sources, include a detailed explanation of the changed circumstances causing this action to now limit the sources. Not applicable.

5) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. Not applicable.

6) An explanation of protests received, if applicable, and actions taken in response to the protest. Not applicable.

b. Other facts. Not applicable.

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11. Technical Certification: I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Laura A. Ballou

Deputy Operative Services Director

12. Requirements Certification: I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Valarie Lawyer-Jefferson Contracting Officer’s Representative

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated price/cost to the Government for this contract action will be fair and reasonable. A price analysis will be conducted to compare the proposed prices to contracts within MRCO-W for the same or similar requirements. I certify that this justification is accurate and complete to the best of my knowledge and belief

Joshua P. Barbero Contracting Officer

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Joshua P. Barbero Contracting Officer

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Approval

Based on the foregoing justification, I hereby approve the procurement of EVO Spherical Lenses and EVO Toric Lenses products on an other than full and open competition basis pursuant to the authority of pursuant to the authority of 41 United States Code 1901 as implemented by RFO FAR 12.102(b), restricting competition for acquisitions valued over the simplified acquisition threshold. `The estimated value of the contract is $1.6 million for a five-year (base and four one-year options) period of performance from 01 October 2026 to 30 September 2031. The approval is subject to availability of funds, and provided that the supplies and/or services herein described have otherwise been authorized for this acquisition.

Cicely D. Simmons-Carroll Advocate for Competition