Unlike correcting contact lenses worn to improve vision, non correcting coloured contact lenses are not presently classified as medical devices. As a result they are not subject to the usual controls rightly imposed on corrective contact lenses by the Directive 93/42/CEE.

The ophthalmic section of the UEMS, which represents some 40,000 ophthalmologists across the EU, wishes to emphasize that whether worn for recreational or esthetic reasons, non corrective coloured contact lenses should still fall within the definition of a medical device. They are often used in clinical practice as a medical prosthesis to camouflage a damaged cornea, or therapeutically to block light so as to alleviate photophobia as seen in albinism, some congenital anomalies or trauma to the iris (1). They modify the anatomy of the anterior surface of the eye.

All contact lenses applied to the front of the eye alter the oxygenation and thereby the metabolism of the cornea. Whatever they are made of must allow adequate oxygen transfer (2). The pigments used for colouring a lens must be non toxic to the ocular surface. The lenses must be stored in sterile packaging to avoid contamination and germ transmission. Their manufacture must answer to all the strict quality and tracking norms so as to be able to guarantee them by the CE mark of products in class IIa.

Contact lenses are the most common cause of corneal infections in developed countries (3). The cases published in the scientific literature in the last few years (4,5,6,7,8,9,10) witnesses the importance of the risk of severe corneal infection (infectious keratitis) associated with non corrective coloured contact lenses. This may result in serious damage to the vision, in some cases requiring a corneal graft. In many cases, it is the total lack of information and counseling on the rules of hygiene and maintenance of contact lenses which is at the root of infection. In fact, the unregulated sale of these products in supermarkets and on the internet deprives the customer, often an adolescent, from benefiting from recommendations on hygiene and maintenance usually given by a professional. A recent study has shown that the purchase of contact lenses over the internet is a factor in the risk of complications (11).

The Unites States and Japanese governments are aware of these problems and have favourably responded to pressure from professional organisations to class non corrective coloured contact lenses as medical devices and tighten the control of their distribution. As official representative of the ophthalmologists of the European Union, the Section of Ophthalmology of the UEMS demands, in the interest of public health, that the European Commission and the Parliament adopt similar measures for Europe.

References

(1) Cole CJ, Vogt U., Medical uses of cosmetic colored contact lenses. Eye Contact Lens. 2006 Jul;32(4):203-6.

(2) Holden B., Merz G., Critical oxygen levels to avoid corneal oedema for daily and extended wear contact lenses. Invest. Ophthalmol. 1984, 25: 1161-1167

(3) Bourcier T, Thomas F, Borderie V, Chaumeil C, Laroche L. Bacterial keratitis: predisposing factors, clinical and microbiological review of 300 cases. Br J Ophthalmol. 2003 Jul;87(7):834-8.

(4) Johns KJ, O’Day DM. Pseudomonas corneal ulcer associated with colored cosmetic contact lenses in an emmetropic individual. Am J Ophthalmol 1988 Feb 15;105(2):210

(5) Connell BJ, A Tullo, P B Morgan, and M Armstrong. Pseudomonas aeruginosa microbial keratitis secondary to cosmetic coloured contact lens wear. Br J Ophthalmol. 2004 December; 88(12): 1603–1604

(6) Steinemann TL, Fletcher M, Bonny AE, Harvey RA, Hamlin D, Zloty P, Besson M,

Walter K, Gagnon M. Over-the-counter decorative contact lenses: Cosmetic or Medical Devices? A Case Series. Eye Contact Lens. 2005 Sep;31 (5):194-200

(7) Colin J, Aitali F, Malet F, Touboul D, Feki J. Bilateral infectious keratitis in a patient wearing cosmetic soft contact lenses. J Fr Ophtalmol. 2006 Jun;29(6):665-7

(8) Gagnon MR, Walter KA. A case of acanthamoeba keratitis as a result of a cosmetic contact lens. Eye Contact Lens, 2006 Jan;32(1):37-8

(9) Lee JS, Hahn TW, Choi SH, Yu HS, Lee JE Acanthamoeba keratitis related to cosmetic contact lenses. Clin Experiment Ophthalmol 2007 Nov;35(8):775-7

(10) Kerr NM, Ormonde S. Acanthamoeba keratitis associated with cosmetic contact lens wear. N Z Med J. 2008 Nov 28;121(1286):116-9.

(11) Stapleton F, Keay L, Edwards K, Naduvilath T, Dart JK, Brian G, Holden BA. The incidence of contact lens-related microbial keratitis in Australia. Ophthalmology. 2008 Oct;115(10):1655-62.