A primary factor in the successful outcome of any surgical procedure is the quality and performance of the medical devices used by the surgeon.
OPHTEC is able to meet these high quality market standards because of:
• its process-approach based organization;
• an experienced highly qualified R&D team;
• an innovative production line;
• the use of high quality materials.
Process approach
OPHTEC’s organization is based upon a process approach. When activities and related resources are managed as a process a desired result is achieved more efficiently. OPHTEC’s processes are in accordance with the ISO 13485. All the products are CE certified and where applicable, for sale in the USA and other markets as well.
R&D
OPHTEC’s highly qualified R&D team translates customer requirements into new unique products. Special care is taken with the safety and effectiveness of the new idea.
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Suggestions, whishes and ideas for new or improved products come in from ophthalmologists from all over the world. |
Sometimes a clinical study is required. Clinical studies can only be initiated if all pre-clinical tests and validations have been successfully completed.
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The fact that OPHTEC manufactures the entire intraocular lens, gives the research department extra incentive. Options for trying out new models with special optical configurations are always available and in combination with the firm’s small- scale flexibility, this often leads to new products. |
Production processes
All OPHTEC’s Intra Ocular Lenses are manufactured entirely in house. The newest, highly innovative production line is responsible for the manufacturing of the acrylate lenses.
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The high quality of OPHTEC’s hydrophilic acrylic lenses is due to its “state of the art” integrated lens manufacturing precision technology |
This fully automated manufacturing process is able to make the IOL’s with high precision. This results in lenses with an aberration free central optical zone. This high precision also enables OPHTEC to reproducible manufacture its lenses.
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“Humming robots with waving arms guide semi-manufactures via barcode readers to and from various processing centers” |
In a clean room all lenses are inspected. With optical equipment, magnifiers and phase contrast microscopes. The lenses are sterilized in accordance with European and FDA guidelines.
Materials
A patented material is used for OPHTEC’s hydrophilic acrylic lenses. By utilizing a unique chemical process batch-to-batch variability is minimized. The residual monomer content is lowered by this process. All lenses are free from air bubbles, inclusions and material pollution.
OPHTEC’s PMMA Lenses are manufactured by using Compression Molding Technology. During the compression molding process the molecular structure of PMMA is enhanced by redistributing the molecules into longer chains. This result in a much stronger material, a high tensile strength, combined with superb flexibility. The risk of fracture is minimal.
The light filtering ability of OPHTEC’s orange filter, used in the Orange lens, is the result of the use of molecules that filter light, anchored in a basis material, a silicon polymer. This results in light transmission providing comfort to the eye of the age group where most cataract patients are found.
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Orange-filter; Research is being done in qualified laboratories to test the lens material for chemical and physical safety. |
Worldwide delivery
In order to ensure the product reaches the user in good condition; final products are treated with special concern. Classified transport packaging is used to protect products during transport to a distributor or end user. OPHTEC and their distributors use courier services to ensure delivery is carried out as efficiently as possible. Full traceability of the products is ensured.
