Industry Sector Report: OR Suite.
Concern over prior authorization requirements.
Zeiss IOL Master V 3.0.1 A Scan
• Unit is in excellent overall condition
• Software Version 3.0.1
A non-contact optical device that measures the distance from the corneal vertex to the retinal pigment epithelium by partial coherence interferometry, the IOL Master is consistently accurate to within ±0.02 mm or better. The IOL Master is the first such device to be widely used in clinical ophthalmology. Calibrated against the ultra-high resolution 40-MHz Grieshaber Biometric System, an internal algorithm approximates the distance to the vitreoretinal interface, for the equivalent of an immersion A-scan ultrasonic axial length.
Considering the fact that axial length measurements by A-scan ultrasonography (using a standard 10-MHz transducer) have a typical resolution of 0.10 mm to 0.12 mm, axial length measurements by the IOL Master represent a fivefold increase in accuracy.
The IOL Master allows fast, accurate measurements of eye length and surface curvature, necessary for cataract surgery. The IOL Master is more efficient because it allows measurements to be taken with complete confidence in the accuracy of the results. Also, because the IOL Master is non-contact (nothing touches the eye itself), there is no need for anesthesia and there is no potential for spread of contamination from the IOL Master.
The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. If so, do not purchase this item unless you are an authorized purchaser. If the item is subject to FDA regulation, I will verify your status as an authorized purchaser of this item before shipping of the item. If you have questions about legal obligations regarding sales of medical devices, you should consult with the FDA's Center for Devices and Radiological Health: http://www.fda.gov/cdrh/industry/support/index.html