The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR Part 13.106-1(b)(1)). The proposed source is AMO Sales and Services, INC. of 1700 East St. Andrew Place, Santa Ana, CA 92705, who is a distributor of the manufacturer Johnson & Johnson Vision. The Naval Medical Logistics Command has a requirement for one (1) aberrometer ECRI #[24-553] for Naval Medical Center (NMC) Portsmouth. The wavefront aberrometer shall be compatible with the currently installed ophthalmic surgical laser systems at NMC Portsmouth listed in Table 1. The unit shall create a three-dimensional (3D) map of the eye to determine the proper format for laser eye surgery procedures. The unit shall be indicated for use in photorefractive keratectomy (PRK) and Laser-Assisted In Situ Keratomileusis (LASIK) procedures. The wavefront aberrometer shall be FDA approved for LASIK treatment of myopia and myopic astigmatism, up to 5 diopters and spherical equivalent of -11.0 diopters, in patients 18 years of age and older. The electrical requirements are 110 V, 60 Hz, single-phase.
AMO Sales and Services, Inc .is the only vendor that can provide a wavefront aberrometer that can function and interface with the currently installed ophthalmic surgical laser systems at NMC Portsmouth. No other vendors can provide a wavefront aberrometer that can function and interface with the currently installed laser system at NMC Portsmouth. The compatibility with the currently installed laser system at NMC Portsmouth is essential for the planning and treatment of PRK and LASIK procedures. The currently installed laser system at NMC Portsmouth has proprietary licensing and software which can only interface with Johnson & Johnson equipment. If a different wavefront aberrometer were to be procured than a different laser system would have to be procure at an estimated value of $205,425.00. Additionally, AMO Sales and Service, Inc. can provide a wavefront aberrometer which is FDA-approved to treat patients 18 years of age, which increases the existing FDA-approved treatment range. AMO Sales and Service, Inc. is the only vendor that meets the minimum requirements of the Government.
Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.
The system, including claims made for the product, shall be compliant with FDA regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. The system shall be installed in compliance with OSHA requirements.
This acquisition is being conducted under simplified acquisition procedures (IAW FAR 13.106-1(b)(1)). There are no set-aside restrictions for this requirement. The intended procurement will be classified under North American Industry Classification System (NAICS) 339112 with a Small Business Size Standard of 1000 employees. This notice of intent is not a request for competitive proposals; however, if a vendor challenges the basis of this requirement, please email challenges and product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Kara Williams at [email protected], reference solicitation number N62645-19-Q-0035. Closing date for challenges is no later than 0900 Local Time, 05 August 2019. No phone calls will be accepted. Please note that a determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.

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