Contact Lens Manufacturing and Regulations

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What is the main purpose of using a diamond-tipped tool in the lathing process of soft lens manufacture?

To lathe the back (concave) surface of the lens

What is a major limitation of using lathing in soft lens manufacture?

Complex designs are difficult to produce

What is the role of centrifugal forces in the spin casting process of soft lens manufacture?

To distribute the monomer across the mould

What is a major advantage of spin casting over lathing in soft lens manufacture?

Higher volume manufacture and lower cost per lens Signup and view all the answers

What additional step may be necessary after spin casting to achieve a smooth lens edge?

Polishing the lens edge Signup and view all the answers

How does the reproducibility of spin casting compare to moulding in soft lens manufacture?

Spin casting has poorer reproducibility than moulding Signup and view all the answers

What are the stages involved in the manufacture of hydrogel contact lenses?

Liquid monomer introduced between moulds, cured (UV/heat), inspected, hydrated, inspected, blister packaged, and autoclaved Signup and view all the answers

What are the advantages of moulding in high volume manufacture of contact lenses?

Low cost per lens, rapid volume production, easy, good surface quality, and good reproducibility Signup and view all the answers

What is a limitation of the moulding process in contact lens manufacture?

Expensive to start production, expense limits parameter range Signup and view all the answers

What is a growing concern among patients related to contact lens use?

The environmental impact of disposable lenses Signup and view all the answers

What aspect of contact lens manufacture has a significant environmental impact?

The use of single-use plastic Signup and view all the answers

What is an important consideration for eye care professionals when advising patients on contact lens options?

The environmental impact of lens manufacture, including the annualised waste of different wearing modalities and recycling options Signup and view all the answers

What is the classification of contact lenses according to the Medical Devices Directive 93/42/EED?

Class IIa – medium risk Signup and view all the answers

What is the purpose of the CE marking on medical devices?

To show that the medical device meets the relevant requirements of the Directive and is fit for its intended purpose Signup and view all the answers

What is the primary responsibility of the MHRA in the UK?

Regulating medicines and medical devices Signup and view all the answers

What is the title of the International Standard that specifies safety and performance requirements for contact lenses and care products?

ISO 14534:2011, Ophthalmic optics – Contact lenses and contact lens care products – fundamental requirements Signup and view all the answers

What is the name of the material used to manufacture soft contact lenses?

HEMA, PHEMA or Poly HEMA Signup and view all the answers

What is the process of creating a soft contact lens from an anhydrous material?

Slicing the material into buttons, shaping the button before hydrating to form the finished soft lens Signup and view all the answers