36C24126Q0630.docx

SUBJECT*

Cataract - Katena Surgical Instruments

GENERAL INFORMATION

VA Connecticut

950 Campbell Avenue West Haven CT 06516

POINT OF CONTACT*

Contracting Specialist Chadwin Walker chadwin.walker@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

DESCRIPTION

Katena Cataract Surgical Instruments This notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.101(a)(2) requiring the dissemination of information on proposed contract actions. This is a notice of intent to award a sole-source contract pursuant to 10 U.S.C 2304 (C)(1), as implemented by FAR 6.302-1(a)(2) and 6.301-1(c), only one responsible source and no other supplies or services will satisfy agency requirements.

The Department of Veterans Affairs Manchester VA Medical Center located at 718 Smyth road Manchester, NH 03104-7007 has a requirement for Katena brand Catarac Surgical Instruments. The Manchester VA Medical Center performs cataract surgeries as part of its ophthalmology services for veteran patients. Existing cataract instrument inventory has reached the end of its usable life and requires replacement to maintain surgical efficiency, safety, and quality of care. Standardization of instruments is critical to ensure consistency in surgical techniques and outcomes.

Cataract Katena Surgical Instruments will serve the following primary functions:

The intended Contractor is Melling LLC, 658 S Columbus ST Alexandria, Virginia 22314.

The Government intends to award a firm-fixed-price sole source contract.

A determination by the Government not to compete with this proposed contract based upon responses to this notice is solely within the discretion of the Government. This notice of intent is not a request for competitive proposals. This is a written notice to inform the public of the Governments intent to award on a sole source basis.

Interested parties may identify their interest and capability to respond to the requirement. Any response to this notice must show clear and convincing evidence that competition will be advantageous to the Government.

Please contact Chadwin Walker, Contracting Specialist with responses or questions regarding this requirement at chadwin.walker@va.gov. No telephone calls please.

This notice will close on June 9th, 2026 at 1:00PM Eastern Standard Time (EST).

Special Notice Special Notice

Special Notice

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition Threshold

Acquisition Plan Action ID: 36C241-26-AP-2812

1. Contracting Activity: Department of Veterans Affairs, Network/Program Contracting Office 1, located at West Haven, CT, in support of the Manchester VA Medical Center.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

The Manchester VA Medical Center Sterile Processing Services (SPS) Department requires the procurement of Katena brand specialized ophthalmic surgical instruments manufactured by Corza Medical to support cataract surgery procedures. These instruments are designed specifically for precision microsurgical techniques used in the removal of cataracts and implantation of intraocular lenses. The requested supplies include, but are not limited to, microsurgical forceps, scissors, needle holders, speculums, and other ophthalmic instruments essential to cataract extraction procedures. These instruments are engineered to meet the exacting standards required for delicate ocular surgery, ensuring optimal control, accuracy, and patient safety.

The intended use of these instruments is to replace the current cataract surgical inventory, which has reached the end of its usable life or no longer meets clinical performance standards. The replacement will ensure continuity of care, maintain surgical efficiency, and support high-quality outcomes for Veteran patients undergoing cataract surgery within the facility.

Katena instruments are being specified to maintain consistency with existing surgical protocols, ensure compatibility with current techniques and surgeon preferences and uphold the established standard of care within the department.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Katena ophthalmic surgical instruments possess unique design characteristics and manufacturing standards that are essential for cataract surgery and are not readily available from other manufacturers without compromising clinical performance and surgical outcomes. These instruments are specifically engineered for ophthalmic microsurgery, with precision tops, balance, and tactile feedback that meet the exact requirements of cataract extraction and intraocular lens implantation.

Key distinguishing features include high-grade surgical stainless-steel construction, specialized tip geometry for delicate ocular tissue handling, and consistent instrument calibration that ensures reproducibility across procedures. The instruments are designed to integrate seamlessly with existing surgical techniques and workflows currently utilized within the facility, minimizing variability and reducing the risk of intraoperative complications.

Additionally, the clinical staff and surgeons are trained and experienced in the use of Katena instruments. Transitioning to alternative manufacturer would require retraining, evaluation, and validation of new instruments, which could introduce delays, increased costs, and potential patient safety risks during the transition period.

While other manufacturers may offer similar categories of ophthalmic instruments, they do not provide the exact combination of precision, compatibility, and surgeon familiarity required to maintain the current standard of care. Substituting alternative instruments could result in decreased surgical efficiency, altered tactile response, and potential impacts on patient outcomes.

For these reasons, Katena instruments are the only source capable of meeting the VA’s minimum requirements for performance, compatibility, and continuity of care in cataract surgery services.

4. Description of market research conducted and results or statement why it was not conducted: A SBS search for NAICS 339112 and keyword “opthalmic surgical instruments” returned 36 results. Additionally, an ADDSUP search with the keyword “opthalmic surgical instruments” found 6 capable vendors; OPTICS INCORPORATED, ALCON VISION LLC, LOMBART BROTHERS, INC, MELLING LLC, L1 ENTERPRISES INCORPORATED, and O R ELDER INC. Correspondence with the Manchester VAMC resulted in a need for the Katena brand ophthalmic surgical instruments concluding that only Melling LLC is authorized and capable to provide the requirement.

Several manufacturers and suppliers of ophthalmic surgical instruments were identified; however, upon further evaluation these sources did not meet the VA’s minimum requirements for compatibility, standardization, and clinical performance. Specifically, alternatives instruments lacked precise design characteristics, consistency, and surgeon familiarity associated with Katena Products, INC., instruments currently in use within the facility.

Clinical feedback from ophthalmology staff confirmed that deviation from the existing Katena instrument platform would introduce variability in surgical performance, require additional training and validation, and could potentially impact patient safety and procedural outcomes. Based on the results of the market research, Katena branded othalmic surgical instruments is the only responsible source capable of meeting the Government’s requirements for the procurement.

An initial market research survey with Melling LLC found that Katena brand ophthalmic surgical instruments are proprietary to Corza medical which is the Original Equipment Manufacturer (OEM). Corza provided a sole source letter stating that only Melling is authorized to distribute their products. Melling is a SDVOSB distributor making this a SDVOSB sole source requirement. GSA advantage was searched with keyword “Katena” which resulted in contract# 36F79722D0189 which was awarded to Melling Medical. There is no NMR waiver for ophthalmic instruments for NAICS 339112. Without the NMR Waiver, per VAAR 819.7003(d), there cannot be a SDVOSB set-aside. With the SBA NMR Exception, per FAR 19.502-2(a), the requirement is eligible for a Straight SB Set-Aside. However, due to the Rule of Two not being met and only one source is able to provide the requirement, the recommendation is a sole source to the SDVOSB distributor Melling LLC.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR 13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer

Page 1 of