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Just The Facts... Critical Features of a LASIK Blade There are five critical features in every microkeratome blade that determine the quality and consistency of the corneal flap.
Cutting Edge – the cutting edge must be free from all defects and imperfections. Any defect in the cutting edge will produce a tear in the tissue resulting in a less than perfect outcome. A blade without defects produces a clean and precise cut. Surgin, a leading manufacturer of lasik blades, is dedicated to providing the industry with high quality innovative products at a cost effective price. Surgin blades are specifically manufactured for the LASIK procedure. Surgin manufactures its Prizm blades from a proprietary 420-modified surgical stainless steel and uses a special honing process to produce a precise, defect-free cutting edge. Surgin's stainless steel contains a higher carbon content that allows for a finer honing of the cutting edge without generating imperfections or "bitemarks." During the final manufacturing process, all blade edges are 100% inspected under high magnification. Other manufacturers use off-the-shelf razor blade stock to manufacture their microkeratome blades. Razor blade stock is available in various hardnesses and the cutting edges can be full of microscopic imperfections and bitemarks. Standard magnification from a surgical microscope cannot detect all defects, but a scanning electron microscope shows all imperfections. Cutting Edge Angle – the cutting edge angle may determine the thickness of the corneal flap. Shallower angles may cause thinner flaps (buttonhole) and steeper angles may cause thicker flaps. To get consistently similar results, compatible blades should have the same cutting edge angle as the original equipment manufacturer. All Prizm blades are guaranteed to have a final cutting edge angle equal to that of the original manufacturer.Blade Symmetry and Blade Straightness – a blade is symmetric if the cutting edge is centered within the thickness of the blade. A blade which is not symmetric may affect the thickness of the flap depending on which way the blade is asymmetric. All Prizm blades are 100% inspected, using automated visual inspection systems, to determine if the symmetry and straightness of each blade is within a tolerance of .0003 inches. Surgin is able to keep such a tight tolerance because it manufactures its own blade stock and does not use off-the-shelf razor blade stock. A tolerance of .0003 inches for these specifications will result in a reliable and consistent flap.All other critical dimensions such as length, width, and thickness are inspected to specific tolerances using automated visual inspection systems. Blade Cleanliness – this is the most demanding process in manufacturing a LASIK blade. Surgin has developed a proprietary cleaning process to insure that all blades are free of debris and residue. A careful inspection of blades currently on the market reveals tiny bits of residue stuck on the cutting edge. If this residue is not removed prior to use in surgery, it may be deposited onto the corneal tissue after the first pass of the blade. Surgin is so confident of its cleaning process that it has developed an exclusive holding case* for its blades that allows for the microscopic inspection of both sides of the blade prior to use.Compatibility The Original Equipment Manufacturer claims that they have not validated the design or performance of the Prizm Blade on their microkeratome. Is that true? Surgin is not sure if they have or not. Surgin is sure, however, that it has successfully performed mutual compatibility testing of its Prizm blade product line on each microkeratome, in accordance with the original manufacturer’s instructions. Surgin can state with certainty that it is in compliance with all FDA and ECC Directives including FDA’s Quality System Regulations (QSR) and the ISO 9001 Total Quality System. How can I be sure that the quality of the Prizm Blades manufactured by Surgin meet the same quality standards as that of the original manufacturer? Surgin is in compliance with the FDA’s Quality System Regulations (QSR). Surgin is also ISO 9001 certified and must meet the same international standards for Total Quality Assurance Management Systems that were established in 1987 for all companies who design/develop, produce, install, and service products. Liability Are the Prizm blades CE marked? Surgin’s Prizm Blade product line is CE marked for sales in Europe. Does Surgin warranty its Prizm Blade product line and does Surgin have liability insurance? As a medical device manufacturer, Surgin warranties all its products, including the Prizm Blade product line. Surgin is insured for product liability. Should you have any other questions or concerns, or would like additional information about the advantages of Surgin’s Prizm blades, please feel free to call us at 714.832.6300 or email us at surgin@surgin.com * Patent Pending |
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