6515--SD/664_PHACOEMULSIFICATION UNITS CATARACT EXTRACT Stellaris Elite Anterior Deluxe

Sources Sought Synopsis Only THIS REQUEST FOR INFORMATION (RFI)/SOURCES SOUGHT/RFI IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY. THIS IS NOT A SOLICITATION. THE SUBMISSION OF PRICING, CAPABILITIES FOR PLANNING PURPOSES, AND OTHER MARKET INFORMATION IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI IN ACCORDANCE WITH (IAW) FAR 15.201(e). The purpose of this synopsis is to gain knowledge of potential qualified sources and their size classification (hubzone, 8(a), small, small disadvantage, veteran owned small business (VOSB), service-disabled veteran owned small business (SDVOSB), or large business relative to NAICS 339112 with size standards of 1000 employees. This sources sought is neither a request for competitive proposals nor solicitation of offers. This synopsis is to assist the VA in determining sources only and a solicitation is not currently available. Note that if VA s pending market research establishes that two or more VOSB or SDVOSB, who are certified in U.S Small Business Administration site https://www.sba.gov can perform the project, VA will set aside the underlying solicitation per 38 U.S.C. §8127. Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. After review of the responses to this Sources Sought Synopsis, a solicitation announcement may be published on SAM, and/or GSA eBuy. Responses to this Sources Sought Synopsis are not considered adequate responses to the solicitation announcement. General Requirements: The Department of Veterans Affairs (VA), VA San Diego Healthcare System, has a need for the Stellaris Elite Anterior Deluxe System and Ultrasound Phaco Handpiece. The system being requested will be by Ophthalmic surgeons performing cataract surgery and or phacoemulsification. The requirement is for brand name or equal to: Stellaris Elite Anterior Please Identify any domestic alternatives (meaning manufactured in the United States) Nomenclature: Phacoemulsification System MANUFACTURE Bausch and Lomb Americas, Inc CLIN Item # Description Qty Unit of Measure 1 BL11145 Stellaris Elite Anterior Deluxe System, V5-2.5K 1 EA 2 BL3170 Stellaris Ultrasound Phaco Handpiece 10 EA REQUIREMENTS: The Ophthalmic department requests the acquisition of the equipment system above to provide the patient population requiring surgical removal of cataracts or other procedures for which the system s indicated capabilities are appropriate in the anterior segment of the eye.. The Salient Characteristics must include: ULTRASOUND MODE Must have a maximum power: 35 Watts at approx. 900 ohms Must have a nominal frequency of 28.5 kHz Must have a pulse mode range of 1 to 250 pulses per second Must have dual linear functionality INFUSION SYSTEM Must have a gravity automated IV pole with a bottle travel range of 110cm Must have an air forced infusion (AFI) of 150 mmHg maximum air pressure Must have air tamponade function ATTUNE ENERGY Must have Attune energy management that works synergistically with the chamber stability and vacuum efficiency of Adaptive Fluidics to deliver highly efficient, controlled emulsification. Must be highly efficient, controlled emulsification with a six crystal 28.5 kHz handpiece frequency. SLEEVES AND PROPRIETARY NEEDLES Must have 5 sleeves to address incisions size from 1.8mm to 2.8mm Must have MICS needles (straight and angled) to offer optimized opening for holdability. Must have a narrow inner shaft to optimize vacuum and minimize post occlusion surge WIRELESS FOOTPEDAL WITH INTEGRATED LASER CONTROLS Must have a Dual linear functionality that allows for independent control of both vacuum and phaco energy on a single pedal Must be wireless and programmable Participating Healthcare Facilities: VISN 22 West VA San Diego Healthcare System 3350 La Jolla Village Drive; San Diego, CA 92161-0002 In response to this announcement, please complete the information below: Company: Address: Contact Name: Phone No: Email: DUNS: Business size information Select all that applies: Small Business Emerging Small Business Small Disadvantaged Business Certified under Section 8(a) of the Small Business Act HubZone Woman Owned Certified Service-Disabled Veteran Owned Small in Vetbiz.gov Certified Veteran Owned Small Business in Vetbiz.gov Large Business Other:____________ All offered items must be listed on vendor FSS contract FSS/ GSA Contract Holder of the requested item(s) Yes No FSS/ GSA Contract Number Effective Date / Expiration Date Country of Origin (COO) Does your company manufacture the requested product(s)? If no, answer the questions below. Yes No Does your company exceed the 500-employee alternative size standard for nonmanufacturers? Yes No Is your company primarily engaged in the retail or wholesale trade and normally sell the type of product(s) being supplied? Yes No Does your company take ownership or possession of the products(s) with its personnel, equipment, or facilities in a manner consistent with industry practice? Yes No Does your company supply the end product(s) of a small business manufacturer or processor made in the US, or obtain a waiver of such requirement? Yes No Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services under the same or a related NAICS codes. Not applicable List: Note* The Non-Manufacturer Rule (NMR) in accordance with 13 CFR § 121.406, September 4, 2019 applies to this acquisition. Additionally, as prescribed on 25.1101(a)(1). FAR 52.225-1 Buy American Supplies and FAR 52.225-2 Buy American Certificate applies to this acquisition. a) For small business set-asides other than construction or service contracts the prime contractor that s supplying products to the government is required to cover at least 50 percent of the cost of manufacturing those products. The non-manufacturer rule is an exception to that requirement. The rule allows a small business to supply products it did not manufacture as long as those products come from another small business. b) A manufacturer is defined as a business that, with its own facilities, performs primary activities in transforming inorganic or organic substances, including the assembly of parts and components, into the end product being acquired. In other words, a manufacturer makes or produces products. Businesses may qualify as a non-manufacturer if it meets the following criteria: · Does not exceed 500 employees · Is primarily engaged in the retail or wholesale trade and normally sells the type of products being supplied · Will supply the end products of a small business manufacturer or processor made in the United States, or obtains a waiver of such requirement See Title 13 Part 121.406 of the Code of Federal Regulations (CFR) for detailed information about the non-manufacturer rule. FAR 52.225-1 Buy American American-Supplies (Oct 2022) (a) Definitions. As used in this clause Commercially available off-the-shelf (COTS) item (1) Means any item of supply (including construction material) that is (i) A commercial product (as defined in paragraph (1) of the definition of commercial product at Federal Acquisition Regulation (FAR) 2.101); (ii) Sold in substantial quantities in the commercial marketplace; and (iii) Offered to the Government, under a contract or subcontract at any tier, without modification, in the same form in which it is sold in the commercial marketplace; and (2) Does not include bulk cargo, as defined in 46 U.S.C. 40102(4), such as agricultural products and petroleum products. Component means an article, material, or supply incorporated directly into an end product. Cost of components means (1) For components purchased by the Contractor, the acquisition cost, including transportation costs to the place of incorporation into the end product (whether or not such costs are paid to a domestic firm), and any applicable duty (whether or not a duty-free entry certificate is issued); or (2) For components manufactured by the Contractor, all costs associated with the manufacture of the component, including transportation costs as described in paragraph (1) of this definition, plus allocable overhead costs, but excluding profit. Cost of components does not include any costs associated with the manufacture of the end product. Critical component means a component that is mined, produced, or manufactured in the United States and deemed critical to the U.S. supply chain. The list of critical components is at FAR 25.105 . Domestic end product means (1) For an end product that does not consist wholly or predominantly of iron or steel or a combination of both- (i) An unmanufactured end product mined or produced in the United States; (ii) An end product manufactured in the United States, if- (A) The cost of its components mined, produced, or manufactured in the United States exceeds 60 percent of the cost of all its components, except that the percentage will be 65 percent for items delivered in calendar years 2024 through…