LIMITED SOURCES JUSTIFICATION (LSJ)

MV Visumax 600/800 Custom Configured Full System

1. Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, Hospital Supply Division, is the contracting activity.

2. The justification is for an acquisition supporting Fort Campbell in Kentucky. The customer is seeking to acquire a laser eye surgery system: CARL ZEISS: MV VISUMAX 600/800 CUSTOM CONFIGURED FULL SYSTEM. The order can be placed against ECAT Solicitation SPE2DH-21-R-0002 Contract Number SPE2DH-22-D-0005, which is valid through February 14, 2027.

3. The acquisition is for the purchase of the following laser eye surgery system:

Manufacturer: Carl Zeiss Item Description: MV VISUMAX 600/800 CUSTOM CONFIGURED FULL SYSTEM Manufacturer Part Number: 000000-2505-237 Quantity: 1 Each Unit Price:

Total Estimated Dollar Value:

4. The authority waiving the competition requirements is FAR 8.405-6(a)(1)(i)(B), only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized. The use of this authority is necessary to meet the locations’ requirements for 1 Each, MV Visumax 600/800 system. The laser eye surgery system is necessary because this location’s existing laser eye surgery systems have exceeded their life expectancy and they are required to be replaced.

The required laser eye surgery system must satisfy the following minimum requirements established by the aforementioned location:

a. Energy delivery - The system must deliver under 200 nano joules in each laser pulse.

b. Pulse rate- The system must have a minimum pulse rate of 2 megahertz.

c. Pulse duration - The system must have a pulse duration under 600 femtoseconds to minimize damage to the surrounding tissue.

d. Automatically recalculate treatment pattern - The system must automatically recalculate the treatment pattern.

e. Computer-controlled alignment- The system must have computer-controlled alignment technology.

f. Footprint measurement - The system’s footprint measurement must be under 20 square feet.

g. Lenticule extraction procedure – The system must be able to perform Lenticule Extraction

Procedure.

The laser eye surgery equipment will be used to enhance vision of patients in Fort Campbell, Kentucky. It uses energy levels below 200 nanojoules to create a smoother surface on the eye's outer layer (the stromal bed); a smoother stromal bed leads to faster recovery and better long-term vision after the procedure. This system’s pulse rate can reach up to 2 megahertz; a laser's pulse rate is how many individual laser pulses are delivered to the eye per second. This system’s pulse duration lasts under 600 femtoseconds; a pulse duration is the length of time each pulse lasts. Both the pulse rate and the pulse duration impact procedure time; the system’s combination of 2-megahertz pulse rate and 600 femtoseconds delivers energy quickly and efficiently, minimizing heat damage to the surrounding corneal tissue. By automatically recalculating the treatment pattern, the system ensures precise alignment and eliminates the risk of human error inherent in manual alignment. Once initiated, the procedure is fully automated, with the system's laser following this map to precisely reshape the cornea. To ensure the laser is always applied to the correct area, the system automatically recalculates this pattern during the procedure to compensate for involuntary eye rotation (cyclotorsion). The system's computer-controlled alignment function precisely aligns the laser with the patient's visual axis before treatment, by automatically identifying the pupil center and corneal vertex.

Its footprint of under 20 square feet allows the equipment to fit within the limited space of typical clinical rooms. Because the system meets all the above requirements, it is capable of performing lenticule extraction - a minimally invasive laser eye surgery that corrects vision by reshaping the cornea.

The Carl Zeiss laser eye surgery system identified above is the only product currently available on ECAT or in the commercial market that meets all minimum clinical/technical requirements indicated above.

5. The Contracting Officer has determined the contract prices of supplies under the Equipment ECAT multiple award program fair and reasonable. DLA Troop Support will seek an additional price reduction since the order will exceed the simplified acquisition threshold. The Contracting Officer has determined that this acquisition represents the best value to the Government consistent with FAR 8.404(d).

6. The Fort Campbell site team performed clinical requirements assessments through market research in November 2025. They assessed which companies offer a laser eye surgery system capable of meeting all minimum requirements. Market research was done via web search, phone calls with potential vendors, the review of the medical master catalog, and the Emergency Care Research Institute (ECRI). The ECRI is a non-profit medical authority that conducts independent medical device evaluations and analysis.

were found to have similar laser eye surgery systems to the Carl Zeiss.

system. However, the compiled research concluded that only Carl Zeiss has a laser eye surgery system that meets all the minimum clinical/technical requirements.

systems were reviewed against the identified minimum requirements:

Both of the alternative models do not meet minimum requirements

Both of the alternative models do not meet minimum requirement

The system does not meet minimum requirement

The system does not meet the minimum requirement

Additional market research was completed by DLA Troop Support in March 2026 by reviewing DLA ECAT contract catalogs; no additional sources that meet all the listed requirements were found. The DLA Biomedical Engineer also reviewed similar laser eye surgery systems via web searches and concluded that no additional sources that meet all requirements are available.

The MV VISUMAX 600/800 CUSTOM CONFIGURED FULL SYSTEM is available on ECAT via contract SPE2DH-22-D-0005.

7. ECAT vendors have the opportunity to add new products that fall within the scope of the Medical Equipment ECAT program on a quarterly basis. Therefore, any ECAT vendor may add products, including microscope systems, enhancing competition for future acquisitions.

8. DLA Troop Support continually performs market research of microscopes to identify possible other acceptable sources for future acquisitions, in order to overcome the barriers that led to restricted consideration. Furthermore, DLA will continue market monitoring, however, any new item considered for procurement would be required to meet the Government’s minimum clinical requirements that have been listed above. In the event another vendor outside of the Equipment ECAT Program offers laser eye surgery systems, DLA will encourage any such vendor/manufacturer to participate in the Equipment ECAT Program.

9. As the Contracting Officer, I hereby certify that the information contained in this Limited Sources

Justification is accurate and complete to the best of my knowledge and belief.

EVAN LESSIN

Contracting Officer, FSHC

I hereby certify that the requirements that form the basis of this justification are accurate, that these supplies meet the Government's minimum needs, and that this justification is accurate and complete to the best of my knowledge and belief.

Product Specialist