Informed consent and medical devices: the case of the contact lens

It is estimated that 1.65 million people in the United Kingdom wear contact lenses, 97% of whom do so for refractive and cosmetic reasons.1 Contact lens wearers are at risk of sight threatening adverse events such as corneal ulceration, which may lead to scarring and visual loss. The risk of corneal ulceration is approximately 1 in 3000, 1 in 2000, and 1 in 500 patients per year for hard, soft daily wear, and soft continuous wear lenses, respectively.2–4 Informing individuals of the risks associated with contact lens wear, is important both for the wearer and person prescribing the contact lens. For consent to be legally valid it must be informed. This means that patients need information about the nature of an intervention, possible alternatives and, specifically, its benefits and risks. There is no …