6515--NX EQ Scanning Systems: Laser: Optical Biometry (VA-26-00026659)

Combined Synopsis/Solicitation Notice Page 14 of 14 Page 1 of This is a combined synopsis/solicitation for commercial items prepared in accordance with (IAW) the format in Federal Acquisition Regulation (FAR) 12.2, Solicitation, Evaluation, and Award, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; offers are being requested, and a written solicitation will not be issued. Solicitation number 36C10G26R0010 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Proposal (RFP). This combined synopsis/solicitation is issued under the agency's implementation of the Federal Acquisition Regulation (FAR) Overhaul, as adopted through agency class deviation. All applicable provisions, clauses, definitions, and procedures are those contained in the Overhaul text and the agency's implementation deviations. In the event of a conflict with the codified FAR, the adopted Overhaul text governs. The full text of provisions and clauses may be accessed electronically at https://www.acquisition.gov/far-overhaul. A single award Requirements contract will be awarded IAW all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Offers shall contain the terms for cost/price and technical capabilities of brand name or equal equipment. The Government reserves the right to award without discussions. The associated North American Industrial Classification System (NAICS) code for this procurement is 339112 Surgical and Medical Instrument Manufacturing, Product Service Code: 6515 Medical and Surgical Instruments, Equipment, and Supplies and the associated size standard is 800 employees. This procurement action is issued as Full and Open Competition. This acquisition is for a single award Requirements contract with firm-fixed priced (FFP) delivery orders IAW FAR Part 16.5 for Zeiss® IOL Master 700 brand name or equal NX EQ Scanning Systems Laser Optical Biometry and accessories as identified in ATTACHMENT A PRICE COST SCHEDULE - NX EQ SCANNING SYSTEMS LASER OPTICAL BIOMETRY. Offerors shall provide a quote for all Contract Line-Item Numbers (CLINs) listed in ATTACHMENT A PRICE COST SCHEDULE - NX EQ SCANNING SYSTEMS LASER OPTICAL BIOMETRY. The ordering period is for one 12-month base year with four 12-month option years. Delivery is Free on Board (FOB) destination. FFP Orders will be placed against this contract in writing and will provide the delivery locations, delivery dates and exact quantities.  The FAR provision at 52.212-1, Instructions to Offerors-Commercial Products And Commercial Services, applies to this acquisition including attached addenda to the provision (see ATTACHMENT D - SOLICITATION PROVISIONS - NX EQ NX EQ SCANNING SYSTEMS LASER OPTICAL BIOMETRY). The FAR provision at 52.212-2, Evaluation-Commercial Products and Commercial Services, and the specific evaluation criteria as attached addenda also applies to this acquisition (see ATTACHMENT D - NX EQ SCANNING SYSTEMS LASER OPTICAL BIOMETRY). Clause at 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services, applies to this acquisition and a statement regarding any addenda to the clause. (see ATTACHMENT C - CONTRACT CLAUSES NX EQ SCANNING SYSTEMS LASER OPTICAL BIOMETRY). All interested Offerors must be registered in the System for Award Management (SAM) prior to submitting a proposal. You may access SAM at https://sam.gov/SAM/. Questions regarding this combined synopsis/solicitation are due via email by 12:00 PM ET on April XX, 2026, to Contract Specialist, Lisa.thompson10@va.gov, and Contracting Officer, Hosea Berkley at Hosea.berkley@va.gov. No questions will be accepted after the due date. No calls will be accepted. Offers are due via email by 12:00 PM ET on April XX, 2026, to Contract Specialist, Lisa.thompson10@va.gov, and Contracting Officer, Hosea Berkley at Hosea.berkley@va.gov. PRODUCT DESCRIPTION 1. SCOPE OF WORK: The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Scanning Systems: Laser: Optical Biometry product line as a candidate for a VA-wide (otherwise referred to as national ) requirements contract. A Scanning System: Laser: Optical Biometry is crucial for accurate Intraocular Lens (IOL) power calculations before cataract surgery, ensuring optimal vision after the procedure. It involves measuring the eye's anatomical characteristics, like axial length and corneal curvature, to determine the correct IOL power needed to achieve the desired refractive outcome. A Scanning System: Laser: Optical Biometry is used as part of a cataract surgery procedure. Cataract is the name given to the human lens that lives behind the iris when it becomes cloudy. The human eye has the ability to see or not see based on three things. a. The axial length of the eye. b. The power of the lens. c. The power of the clear surface of the eye (cornea). The lens has magnification power just like the surface of the eye (cornea). If a surgeon removes the human lens, it must be replaced with equivalent power so that all three factors add up to enough power for the eye to see. As an example, 60 diopters at a distance, and 62 diopters to see up close. The biometry device measures the power of the cornea around (40 diopters), measures the power of the lens (around 20 diopters) and then uses the length of the eye (distance between the cornea and the lens and distance of the cornea to the retina). One simple formula is called the SRK/T. The biometry device predicts the power of what the lens power should be to make the patient see clear at a distance or near. The biometry device also predicts what the power of the artificial lens, called intraocular lens implant (IOL), should be if placed in different parts of the eye (in front of the iris or behind the iris). If emplaced behind the iris, it is about 20 diopters and if emplaced in front of iris, it is about 17 diopters. In other words, the Scanning System: Laser: Optical Biometry is the most important diagnostic device to perform cataract surgeries. Without this system, facilities are unable to perform cataract surgeries. The device performs procedures for Current Procedural Terminology (CPT) 76514, 76512, 99174, 92025, and 92136. The surgery CPT codes are 66984, 66982, 66991, and 66989. Within the VA, approximately 70K cataract surgeries are performed annually. The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Scanning Systems: Laser: Optical Biometry to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for a base of 12-months with four, 12-month option periods. 2. REQUIREMENT This requirement will be Brand Name or Equal which requires the quoter indicate that each product being offered as an equal product to the Zeiss® IOL Master 700. For each equal product, the offeror must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The quoter must also clearly identify the item by brand name (if any) and make/model number. Finally, the quoter must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements. The following line-items comprise the Zeiss® IOL Master 700 product line: Contract Line Items Manufacture Part Number Description 0001 Zeiss 266002-2118-007 IOL Master 700 0002 Zeiss 000000-2244-886-40FCZDIC Forum-DICOM Interface The VA is seeking offerors who can provide Zeiss® IOL Master 700 or equal as listed above which meet all SCs listed below. Offerors may quote any product solution or configuration so long as they meet the SCs. Offerors may quote an alternative CLIN structure IAW FAR 4.202-2 and 4.202-3. Products quoted in the technical volume must appear on and correspond with the Offeror s pricing volume (ATTACHMENT A - PRICE COST SCHEDULE - NX EQ NX EQ SCANNING SYSTEMS LASER OPTICAL BIOMETRY). Offerors may quote any additional ancillary products which they deem to be essential to the functionality of the quoted solution; these ancillary items must be quantified in the Offeror s pricing volume with an estimated quantity of zero (0). Only new equipment is acceptable; no remanufactured or "gray market" items. No product in development shall be considered. All items must be covered by the manufacturer's warranty. Distributors must be authorized-distributors/resellers as certified by the Original Equipment Manufacturer (OEM) (i.e., OEM letter dated within 12 months of the solicitation close date and duly signed by OEM s authorized representative) to be eligible for award. The OEM letter must be valid for the life of the contract. SC # SALIENT CHARACTERISTICS METHOD OF EVALUATION Applicable CLIN SC Literature Map SC 1 Must have ability to obtain biometry readings on dense cataracts Manufacturer Meeting, Literature Review 0001 SC 2 Must have at least 3 of the 4 below listed biometry formulas (Barrett, Holladay, Hoffer, Haigis) Manufacturer Meeting, Literature Review 0001 SC 3 Must be capable of providing the surgeon with multiple Intraocular Lens Power options to include anterior chamber, posterior chamber (bag), Sulcus Manufacturer Meeting 0001 SC 4 Must perform keratometry measurements Manufacturer Meeting, Literature Review 0001 SC 5 Must provide calculations for Toric Lenses Manufacturer Meeting, Literature Review 0001 SC 6 Must have ability to compensate for motion artifact (patient moving) Manufacturer Meeting, Literature Review 0001 SC 7 Must be DICOM compatible Manufacturer Meeting, Literature Review 0001, 0002 SC 8 Must provide at least one year warranty Manufacturer Meeting 0001 SC 9 Must integrate and function with both Vista/CPRS and Cerner Manufacturer Meeting 0001 SC10 Must have ability to connect and function with an operating room Microscope Manufacturer Meeting 0001 SC11 Must have ability to perform corneal topography Literature Review, Manufacturer Meeting 0001 SC12 Must have ability to compensate for previous refractive surgeries (RK, PRK, LASIK) when providing an IOL power calculation Manufacturer Meeting, Literature Review 0001 SC13 Must have FDA 510 K approval Literature Review 0001 3. PRODUCT REFRESH  Product refresh is when a current CLIN is no longer being manufactured due to obsolescence and the product item is being replaced with a newer, and more often, a superior version of the same item. The current CLIN product will be revised to reflect the refreshed product information, manufacturer s part number, IDIQ price (inclusive of Service Level Agreement (SLA) fee), etc. The Government reserves the right to not accept the products quoted under product refresh. The contractor will be notified in writing if a product refresh is not accepted. All products quoted shall be provided with the warranty that is agreed upon for this contract. The contractor agrees to ensure that all upgraded improved/replaced products meet American with Disabilities Act (ADA) and Health Information Portability and Accountability Act (HIPAA) Federal requirements. The contractor shall provide the Contracting Officer s Representative (COR) and Contracting Officer the following information for product refresh: (1) A list of specific awarded item(s) being refreshed in the Price/Cost Schedule (to include commercial pricing, discount offered, and IDIQ price (inclusive of SLA fee)); (2) Product literature for the item(s) refreshed. (3) A detailed description of the differences or benefits of refreshed as compared to the item(s) being discontinued or added. (4) Proper identification of any product requirements and/or procedures related to those product(s) quoted to be refreshed or upgraded. (5) FDA approval, if applicable (6) Provide historical sales to VA by item(s), if applicable (7) Copy of Commercial Warranty. The request shall be submitted to the COR for review and recommendation of approval to be submitted to the Contracting Officer. The Contracting Officer shall prepare a bilateral modification for execution. 4. PRODUCT REMOVAL OR RECALL For any product awarded under this contract removed or recalled by the manufacturer due to defects in the product or potential dangers to patients, or if any required removal or recall is suggested or mandated by a regulatory or official agency, the manufacturer agrees to take following steps immediately: Notify the Contracting Officer at the Strategic Acquisition Center in writing, by the most expeditious manner possible. Provide copies of the notification to the Contracting Officer, COR, and Manager at Product Recall Office, all Agencies and VA Facilities who purchased the product, which include, but not limited to the following: (1) Complete item description and/or identification, order numbers from customers and the contract number assigned as a result of an issuance on the solicitation; (2) Reasons for modifications, removal or recall; and (3) Necessary instructions for return for credit, replacement or corrective action. A copy of the notification will be provided to: Manager, Product Recall Office National Center for Patient Safety Veterans Health Administration 24 Frank Lloyd Wright Drive, Lobby M Ann Arbor, MI 48106 5. DELIVERY The Period of Performance will be from date of award for a base of 12-months with four 12-month option periods. Offerors will be required to deliver Bariatric Patient Transfer Lifts and accessories to VHA facilities located in the Continental United States (CONUS) and Outside of the Continental United States (OCONUS). Delivery requirements shall be specified under each individual order. 6. DATA RIGHTS Commercial license agreements may be made a part of this Contract/Order but only if both parties expressly make them an addendum hereto, as permitted by FAR 12.107. If the commercial license agreement is not made an addendum, it shall not apply, govern, be a part of or have any effect whatsoever on the Contract/Order; this includes, but is not limited to, any agreement embedded in the computer software (clickwrap), any agreement that is otherwise delivered with or provided to the Government with the commercial computer software or documentation (shrink-wrap), or any other license agreement otherwise referred to in any document. If a commercial license agreement is made an addendum, only those provisions addressing data rights regarding the Government s use, duplication and disclosure of data (e.g., restricted computer software) are included and made a part of this Contract/Order, and only to the extent that those provisions are not duplicative or inconsistent with Federal law, Federal regulation, the incorporated FAR clauses and the provisions of this Contract/Order; those provisions in the commercial license agreement that do not address data rights regarding the Government s use, duplication and disclosure of data shall not be included or made a part of the Contract/Order. Federal law and regulation including, without limitation, the Contract Disputes Act (41 U.S.C. § 7101 et seq.), the Anti-Deficiency Act (31 U.S.C. § 1341 et seq.), the Competition in Contracting Act (41 U.S.C. § 3301 et seq.), the Prompt Payment Act (31 U.S.C. § 3901 et seq.), Contracts for Data Processing or Maintenance (38 USC § 5725), and FAR clause 52.212-4, 52.227-14 shall supersede, control, and render ineffective any inconsistent, conflicting, or duplicative provision in any commercial license agreement. In the event of conflict between this clause and any provision in the Contract/Order or the commercial license agreement or elsewhere, the terms of this clause shall prevail. The Contractor shall deliver to the Government all data first produced under this Contract/Order with unlimited rights as defined by FAR 52.227-14. Claims of patent or copyright infringement brought against the Government as a party shall be defended by the U.S. Department of Justice (DOJ) IAW 28 U.S.C. § 516; at the discretion of DOJ, the Contractor may be allowed reasonable participation in the defense of the litigation. Any additional changes to the Contract/Order must be made by modification (Standard Form 30) and shall only be made by a warranted Contracting Officer. Nothing in this Contract/Order or any commercial license agreement shall be construed as a waiver of sovereign immunity. ATTACHMENT A - PRICE COST SCHEDULE - NX EQ SCANNING SYSTEMS LASER OPTICAL BIOMETRY ATTACHMENT B - CONTRACT ADMINISTRATION - NX EQ SCANNING SYSTEMS LASER OPTICAL BIOMETRY ATTACHMENT C - CONTRACT CLAUSES - NX EQ SCANNING SYSTEMS LASER OPTICAL BIOMETRY ATTACHMENT D - SOLICITATION PROVISIONS - NX EQ SCANNING SYSTEMS LASER OPTICAL BIOMETRY ATTACHMENT E - QUARTERLY SALES REPORT - NX EQ SCANNING SYSTEMS LASER OPTICAL BIOMETRY ATTACHMENT F - PAST PERFORMANCE REFERENCES - NX EQ SCANNING SYSTEMS LASER OPTICAL BIOMETRY ATTACHMENT G - PAST PERFORMANCE QUESTIONAIRE - NX EQ SCANNING SYSTEMS LASER OPTICAL BIOMETRY