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Ophthalmology

Ophthalmology

 

For decades, Saint-Gobain has been leading the way with innovative manufacturing of custom specialty components for ophthalmic devices.  Our tooling expertise ensures novel tool designs for precise shutoffs, intricate features, and minimized flash.  In addition to serial production tooling manufacturing, Saint-Gobain’s metal 3D printing of mold inserts allows for rapid prototyping of silicone molded parts enabling a faster design cycle for our customers.  Instrumentation and devices used in ophthalmic procedures continue to evolve and miniaturize creating smaller incisions and reduced patient trauma. Saint-Gobain has continued to innovate alongside our customers to design and manufacture micro-silicone components needed to provide precise fluid management for use in cataract and vitreoretinal eye surgeries. 

 

Cataract

Precision silicone components are critical during phacoemulsification (phaco for short) procedures.  The standard for micro-incisions for ophthalmic procedures has decreased from a standard incision of 2.75mm-3.2mm down to a biaxial micro-incision less than 1mm, with some micro coaxial incisions being about 1.5mm.  As such, the fluid dynamic requirements change around irrigation/aspiration ports of infusion sleeves. Saint-Gobain’s advanced manufacturing methods provide specialty designs for the aspiration port and can provide rapid prototypes of various designs to aid our customers in determining the best design with optimal fluid dynamics. Saint-Gobain offers a standard silicone test chamber which is also used in phaco procedures. In addition to the standard product offering, customization to the customer’s specification is also an option.

 

Vitreoretinal

The use of valved trocar cannulas during vitreoretinal procedures has been shown to enable more precise control of intraocular pressure (IOP) as well as reduce the damage done to the eye during these procedures.  In the last few decades, there has been extensive comparison of valved and non-valved cannulas for vitreo-procedures.  The use of these components have become a mainstay for many procedures such as corneal transplants and repairing damaged or detached retinas because practitioners can maintain a very steady IOP during the procedure   Many of the solutions offered to practitioners require micro silicone molded parts or micro over-molded parts all with precise tolerances and minimized flash. Saint-Gobain provides micro-molded critical ophthalmic parts, manufactured in our class 8 clean room, via our world class silicone processing know-how, experience in micro silicone injection molding, and tooling expertise ensuring each part meets the customer’s print specifications.

 

Additional Components

Silicone components are utilized in many ophthalmic devices and procedures. Saint-Gobain offers best in class material and processing expertise. Selecting the best material for the application and ensuring the device’s design requirements are met can be challenging and time consuming for our customers.  Saint-Gobain’s deep knowledge of the physical properties of a wide array of silicone formulations means we can recommend formulations that will be best suited for the demands of the application. This can minimize the need to test multiple iterations and options thereby reducing time in your development cycle. Speak to our applications engineering team about how we can help with your next molded or extruded silicone part.  With decades of experience from in-house tooling design to precision extrusion to micro silicone injection molding, we offer unparalleled expertise in medical device component manufacturing within the ophthalmic device market.

 

About Saint-Gobain

Saint-Gobain designs, manufactures and distributes materials and solutions which are key ingredients in the wellbeing of each of us and the future of all. They can be found everywhere in our living places and our daily life: in buildings, transportation, infrastructure and in so many industrial applications.

 

Saint-Gobain Performance Plastics' group of businesses gather solutions to save energy, provide protection, improve comfort and sustain the environment for a variety of markets.

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Saint-Gobain’s medical products are distributed exclusively to medical device manufacturers for use in the manufacture, assembly or distribution of their medical devices. Saint-Gobain cannot authorize the sale of its medical products directly to device user facilities (e.g. hospitals, surgery centers, nursing home, clinics, etc.), nor directly to end users (e.g. patients, patients’ caregiver, prescribing physician, nurse, pharmacist, etc.), including distributors serving device user facilities and end users directly. In accordance with every jurisdiction globally, Saint-Gobain’s customers are responsible for determining that any medical device they manufacture and market that incorporates a Saint-Gobain’s medical product, is compliant with each country-specific medical device regulations and has received proper country-specific clearance, certification or registration authorizing the sale of this medical device.


Saint-Gobain’s medical products offer covers:
- Medical Components [21 CFR 820.3(c)], intended for processing or use in the manufacture or assembly of medical devices before the finished medical device is packaged/labeled; Medical Components are intended to be included as part of the finished, packaged, and labeled device [21CFR820.3(c)].
- Finished Devices [21CFR820.3(l)] made on behalf of medical device manufacturers [21 CFR 807.20(a)(2)] under contract-manufacturing agreement. In accordance with the United States’ jurisdiction, Saint-Gobain complies with the FDA’s requirements for contract manufacturers of finished devices.

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