Phacoemulsification Cataract Extraction Unit

DEPARTMENT OF THE NAVY NAVAL MEDICAL LOGISTICS COMMAND SYNOPSIS AND SOLICITATION The Naval Medical Logistics Command intends to negotiate on a sole source basis (IAW FAR 13.501) with Advanced Medical Optics, Inc., 1700 East St. Andrew Place, Santa Ana, CA 92705, as the only responsible source that can provide a phacoemulsification cataract extraction unit that can provide both true peristaltic and true venturi pumps that allow for a physician to instantly switch between the two during a procedure and can internally create its own pneumatic pressure without the need for an external gas supply. Regulatory Requirements: The system and all of the components, 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. This acquisition is being conducted under simplified acquisition procedures FAR 13.501 under the authority of the test program for commercial items (section 4202 of the Clinger-Cohen Act of 1996). There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 334510. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data, including cost, sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on 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. Capability statements shall be submitted by email only as a MS Word or Adobe PDF attachment to [email protected]. No phone calls accepted.