NOI_for_N6890616RC7L002.doc

The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR Part 13.501(a)). The proposed source is AMO Sales and Service, Inc., 1700 E St. Andrew P1, Santa Ana, CA 92705-4933. Naval Medical Center San Diego has a requirement for one (1) femtosecond pulse laser for cataract surgery [28-161]. The system shall be a diode-pumped solid state ophthalmic laser with a wavelength in the near-infrared spectrum designed for use in cataract surgery. The system shall be FDA-approved for anterior capsulotomy, single- and multi-plane corneal cuts/incisions, and phacofragmentation for nuclear, subcapsular, and cortical cataracts. The system shall be indicated for use in patients diagnosed with glaucoma. The system shall be capable of performing each of these operations individually and consecutively. The system shall feature pulse durations in the femtosecond range (<600 femtoseconds) and pulse frequencies greater than 100 Hz. The system shall be capable of conducting three-dimensional Fourier-domain (spectral-domain) optical coherence tomography (OCT) for visualization during the operation. The system shall feature a nonapplanating liquid patient interface (docking system) with intraocular pressure increases no greater than 15 mmHg. The system shall feature automated tilt correction. The system shall include a safety feature to prevent veering from the desired operating area. The system shall include an integrated patient bed. The system shall run an approved operating system and include all hardware and software necessary for full system functionality. Electrical requirements are 220 VAC, 60 Hz.

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 systems shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA, with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements.

If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Yun Hong at yun.p.hong.civ@mail.mil, reference solicitation number N6890616RC7L002. Closing date for challenges is no later than 2:00pm local time on 13 May 2016.