DEPARTMENT OF THE NAVY NAVAL MEDICAL LOGISTICS COMMAND NOTICE OF INTENET TO SOLE SOURCE The Naval Medical Logistics Command intends to increase the quantities on CLIN 0004 of AMO’s 10TX – Addedvue Pak High Myopia Domes, AMO’s 10TX – S4 USA LASIK PRK ASTIG and AMOS’s IFLAP US which are all manufactured by Abbott Medical Optics (AMO) (AMO), 1700 E. St. Andrew Place, Santa Ana, CA 92705, on an existing Indefinite Delivery Indefinite Quantity (IDIQ) : N626454-11-D-5050. The quantity will be increased by 400 units. This procurement will be classified under North American Industry Classification System (NAICS) 339115. Essential Characteristics: The requirement is to add treatment key cards for use with various facilities’ VISX Photo Refractive Keratectomy (PRK) systems. These PRK systems are used to perform fragile procedures on the eye. Each key card shall provide the proprietary information needed to perform a procedure on the key using the VISX systems mentioned below already located at those facilities. These procedures shall include the following: laser treatment for eye ablation to treat myopia, hyperopia, mixed astigmatism treatment, and high myopia treatment for Lasik; laser treatment for ablation of the surface of the eye; and flap creation for use during Lasik surgical procedures. 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. The system shall be installed in compliance with OSHA requirements. IF YOU CAN SATISFY THIS REQUIREMENT, PLEASE SUBMITT YOUR CAPABILITIES STATEMENTS TO
[email protected] NO LATER THAN 4:30 ON FRIDAY, 21 SEPTEMBER 2012.