Over the past few years, I have attended several fancy dress parties at Halloween and at almost every party there is at least one guest who is wearing decorative contact lenses. They can usually be identified by their pained expression and persistent epiphora. On enquiring, 100% of these decorative lens wearers have reported buying their lenses on the internet. 

I have yet to come across a decorative lens wearer, who has said that they had the lenses fitted by a suitably registered eye care professional (ECP). I have often considered quoting them a 2019 literature review of cosmetic contact lens infections,1 but have stopped short, fearing the inevitable social ostracisation that would follow. 

The authors of that particular review note that many decorative contact lenses have poorly manufactured surfaces that make it easy for microorganisms to adhere to and that many others are simply counterfeit.

Contact lenses are classified as medical devices in most countries in the world. In 2019, the European Union (EU) Intellectual Property Office in conjunction with the Organisation for Economic Cooperation and Development produced a report on the trade in counterfeit goods.2 

The authors of the report estimate that 6.8% of imports into the EU were probably counterfeit. The report was based on seizures of counterfeit and pirated goods made in 2016. The report does not specifically mention contact lenses, but in 2016 there were 90 seizures of optical, photographic and medical instruments, which is the category to which contact lenses belong. 

Operation Panagea is an Interpol operation designed to disrupt the supply of counterfeit medical health products. In 2019, analysis of the results of the operation from the previous 10 years suggested that at least 11% of medical products sold online are counterfeit and all regions of the world are affected.3

There is an awareness on the part of eye care professionals and patients about the existence of counterfeit coloured or decorative contact lenses, thanks in no small part to the work of public health bodies and professional associations. Around Halloween in particular, health warnings are commonly seen advising the public of the dangers of buying unregulated, decorative contact lenses.  

In the UK, in 2021, a woman was successfully prosecuted for possessing and selling counterfeit decorative contact lenses. TM Eye Ltd are a private investigations company that carry out investigations into counterfeit goods. In 2018, they bought three pairs of Freshlook colorblends lenses from a 31-year-old, pharmaceutical saleswoman based in Newcastle. 

On analysis the lenses were found to be counterfeit. She had bought the lenses and care solution from Chinese website alibaba.com for £1.75 a pair. She was selling them for £15 a pair via her Facebook page. When her home was raided sticky labels similar to those used to indicate a registered trademark were found along with the lenses and solution. This case was widely reported in the optical and national press at the time.4

Figure 1: A 2017 study found 60% of counterfeit decorative contact lenses were contaminated with microbes


While there is certainly an awareness among ECPs and the public about the existence of counterfeit decorative lenses, fewer people (both ECPs and patients) seem to be aware of the existence of counterfeit clear corrective lenses. In 2004, two patients who bought Proclear Compatibles from the American contact lens website 1-800 contacts (1800contacts.com) were unhappy with the performance of their lenses and complained directly to CooperVision. 

One of the patients returned the lenses to CooperVision and on analysis the lenses were found to be counterfeit and contaminated.5 In a subsequent press release, it was stated that both CooperVision and 1-800 contacts were working with the Food and Drug Administration (FDA) to monitor and correct the situation, but as we will see, establishing the origin of counterfeit contact lenses is akin to searching for a needle in a haystack. 

It was plain luck that these counterfeits were uncovered at all, as most consumers complain directly to the vendor and not the manufacturer. In that same year, counterfeit surevue lenses were uncovered in France. Some opticians tried to return the lenses to a wholesaler in order to exchange them for different powers.6 

When the wholesaler received the returns, they noticed that they were in old packaging, which had been discontinued in 2003. There were also other small differences in the packaging. This was how the wholesaler realised they were fakes. Reports do not make it clear if the wholesaler had unwittingly originally handed out counterfeit product or if the opticians knowingly sent the wholesaler counterfeits for exchange, in what could be described as a case of lens laundering.

In 2018, Alcon had to recall packets of Air Optix Night and Day. The lenses, which had been supplied by Allied Vision Group, a wholesaler based in Florida, were found to be counterfeit. It is not clear how the counterfeit lenses were uncovered but it was estimated that 800 consumers may have received counterfeit product.7

In 2022, Irish ECPs were surveyed anonymously via mobile phone at an education event with the question: ‘Have you ever come across counterfeit contact lenses?’ Of the 90 respondents just under half (41 respondents) had come across counterfeit contact lenses, mostly decorative ones. 

In 2017, a survey of over 1,000 optometrists was conducted on behalf of the AOP and over half of respondents reported seeing patients who had experienced problems after buying contact lenses or spectacles online.8 However, this does not mean that all (or indeed any) of those patients were necessarily wearing counterfeit products.

According to research carried out by the EU most counterfeit products originate in China.2 Counterfeits are often produced in facilities that are geographically close to genuine manufacturing facilities, in order to take advantage of local expertise. Once manufactured, counterfeit lenses are initially exported unlabelled; some websites openly sell unlabelled contact lenses.9 

The lenses may pass through several transit countries (free trade zones are a particular favourite of counterfeiters) before reaching the country in which the counterfeit labelling is applied. This country is usually close to, or even in, the target market for the counterfeit goods. In the past year, UK police have closed down a counterfeiting operation in Manchester, where designer logos were being put onto imported blank clothes.10

How easy is it to spot a counterfeit?

Advising on how to spot counterfeit lenses, Ms Kanabar of the AOP said: ‘Generally, if your normal brand of contact lens is considerably cheaper, it’s more than likely that they are counterfeit.’11 While this may work for decorative contact lenses, it is less applicable to counterfeit clear corrective lenses. 

Online contact lens retailers source their lenses from wholesalers. One large online contact lens selling website states ‘we buy 1,000s of contact lenses from around the world each month from wholesalers’.12 Assuming that this is correct, then it would be difficult for the company to carefully check all the supplies arriving from different wholesalers to ensure there are no counterfeit lenses mixed in. 

In this way, counterfeit lenses may well end up mixed in with genuine product, which means that it will be sold at the same price as genuine product. While the online retailer may not know for certain that the lenses they are buying are fake, the lenses are presumably sold to them at an unusually low price, so they should have their suspicions.

Some of the poor reviews that unsatisfied customers leave online for contact lens retail websites could be considered suggestive of the customer having been supplied with counterfeit product.13

  • ‘I bought three box of lenses with the same strength but the quality is bad!’
  • ‘On the second day of use they literally broke into my eyes and caused extreme irritation.’
  • ‘Second time the lenses were really bad quality, my eyesight was even worse with them on.’
  • ‘The prescription was correct but the lenses are completely wrong. Unable to wear them. Bought the same from my optician, perfect.’
  • ‘The lenses I purchased are making my eyes red and the vision is blurred.’
  • ‘I had to pay for return of faulty/fake lenses myself.’
  • ‘I feel they are selling fake products as there is no other explanation as to why my eyes react badly to these but not the ones sold by opticians.’


Apart from possibly supplying counterfeit lenses (perhaps unknowingly) some online contact lens retailers also engage in other dubious practices, eg recommending alternative own brand contact lenses to consumers in place of the consumer’s prescribed brand and, according to one reviewer, they have been known to suggest that the reviewer might consider ordering a different power, as the reviewer’s prescribed powers were out of stock!13 

Another telltale sign of a less than scrupulous retail website is payment pages that do not have https or a padlock symbol. In the absence of either of these, payment details are unlikely to be held securely. If online retailers want to combat counterfeit lens supply, then they could ask patients who experience adverse reactions to send the lenses to the retailer, so that the lenses could be sent back to the manufacturer, or they could at least recommend that the patient send the lenses to the manufacturer themselves. 

At least one retailer does state that they ‘send [the lenses] for a quality check so that our suppliers will know of any problem as soon as possible’. It is unclear if the retailer carries out these quality checks themselves or where the quality check is performed. Most retailers offer nothing more than apologies.

Are only soft disposable lenses counterfeited?

It is difficult to find any reported cases of counterfeit lenses other than soft disposable, but there are specialist lenses available online for sale direct to the consumer, eg on the website eueyewear.com a patient can buy Rose K lenses if they have their lens specifications.14 

Counterfeiters do not know what a specific contact lens is normally prescribed for and so they could easily see the retail price for a specialist lens and decide that there was considerable profit to be made from counterfeiting that lens. In fact, mass-producing counterfeit specialist lenses with their high retail price, would appear far more profitable than mass-producing soft disposable lenses, particularly if you were unaware of how limited the market is for these particular lenses.

A 2018 comparison of counterfeit lenses and their genuine counterparts found that while the counterfeit lens parameters were within the correct tolerances, their manufacture was sub-standard resulting in thickness variations across the lenses.15 These badly manufactured lenses may result in poor fitting and discomfort. 

In 2017, the Forensic Chemistry Center of the US FDA examined more than 300 decorative contact lenses and found that 60% of counterfeit lenses were contaminated with microbes.16 As counterfeit lenses are not subject to any safety standards there is no need for counterfeiters to waste time and effort on manufacturing their product in a sterile environment. 

In addition to all of this, purchasing counterfeit products helps to fund more serious crime such as terrorism, human trafficking and child labour.17When patients have an adverse experience with counterfeit lenses this can affect their trust in the brand that they normally wear and in the case of very bad experiences, they may be reluctant to wear any type of contact lens again.

ECPs should only ever source contact lenses directly from manufacturers. Most practitioners are probably fitting soft disposable lenses from a maximum of about five different manufacturers and as lenses can be ordered directly from the manufacturers, there is really no good reason to use a wholesaler. 

If you do come across lenses that you suspect are counterfeit, you should immediately contact the lens manufacturer as they are often the only ones who can conclusively verify whether or not lenses are counterfeit. If the lenses are found to be counterfeit, the manufacturer will want to start an investigation into their provenance immediately and they may need to affect a product recall to avoid more counterfeit lenses reaching other consumers.

Patients should also be alerted to the possibility that online purchasing of contact lenses may result in counterfeits being supplied. If the risks to their ocular health are not enough to stop them from purchasing potentially counterfeit lenses, then perhaps knowing that counterfeit products are most commonly produced by slave labour might convince them. 

  • Claire McDonnell is an optometrist and lecturer at Technological University Dublin. She is also a member of BUCCLE (British and Irish University and College Contact Lens Educators). Her research area is specialist contact lenses. She has presented in the UK, Ireland and Europe on contact lenses and optometric education.
  • The author would like to acknowledge contributions from Chloe Allen, Melanie Lucescu, Therese Mc Guill and Guillermo Shields

Disclosure

The author has no financial interest in any of the products or companies stated and has no conflicts of interest to declare.

References

  1. Lim CHL, Stapleton F, Mehta JS. A review of cosmetic contact lens infections. Eye (Lond). 2019 Jan;33(1):78-86. doi: 10.1038/s41433-018-0257-2. Epub 2018 Nov 1.
  2. OECD/EUIPO (2019), Trends in Trade in Counterfeit and Pirated Goods, Illicit Trade, OECD Publishing, Paris/European Union Intellectual Property Office. Available at https://doi.org/10.1787/g2g9f533-en Accessed 31 Oct 2023.
  3. Operation Panagea – shining a light on pharmaceutical crime. 21 Nov 2019. Available at https://www.interpol.int/en/News-and-Events/News/2019/Operation-Pangea-shining-a-light-on-pharmaceutical-crime. Accessed 31 Oct 2023
  4. Newcastle fake contact lens seller fined £2,500. BBC Tyne and Wear 21 April 2021. Available at https://www.bbc.com/news/uk-england-tyne-56834392. Accessed 31 Oct 2023.
  5. Kirby, J. Counterfeit version of CooperVision lenses sold to two 1-800 contacts customers. Review of Optometry 22 Nov 2004. Available at https://www.reviewofoptometry.com/article/counterfeit-version-of-coopervision-lenses-sold-to-two-1-800-contacts-customers. Accessed on 31 Oct 2023
  6. De Brujin, A, de Vries, C, Hermsen, H. Counterfeit medical devices. A risk indication. National institute for public health and the environment. Netherlands. August 2009. Page 9. Available at https://www.rivm.nl/bibliotheek/rapporten/360060001.pdf Accessed on 31 Oct 2023.
  7. Class 2 device recall Air Optix Night and Day Aqua. US FDA. Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=179522. Accessed 31 Oct 2023
  8. Findings from the AOP Voice of Optometry insight panel, the survey was conducted by independent research company, Alpha Research between March – May 2017
  9. Fake designer logo factory raided in Manchester. BBC North West. 11 Oct 2023. Available at https://www.bbc.com/news/uk-england-manchester-67081547 Accessed on 31 Oct 2023
  10. 1 to 5 white contact lenses, packaging type: box. Indiamart. Available at https://www.indiamart.com/proddetail/contact-lenses-8523301297.html Accessed on 31 Oct 2023
  11. AOP responds to Fake Britain on counterfeit contact lenses. 16 Aug 2019.Available at https://www.aop.org.uk/our-voice/media-centre/press-releases/2019/08/16/aop-responds-to-fake-britain-on-counterfeit-contact-lenses Accessed on 31 Oct 2023
  12. Buy wholesale contact lenses. Contactlensesplus.ie Available at https://www.contactlensesplus.ie/page/wholesale Accessed on 31 Oct 2023
  13. Reviews taken from Trustpilot.com on 1 March 2022
  14. Menicon Rose K2 PG. Eueyewear.com. Available at https://www.eueyewear.com/eueyewear_en/menicon-rose-k2-pg.html Accessed on 31 Oct 2023
  15. Coldrick B, Hall L, Drew T, Richards C, Sugden K, Wolffsohn J, Objective comparison of counterfeit contact lenses to genuine contact lenses, Contact Lens and Anterior Eye, 41, Supplement 1, 2018, Page S34
  16. Land AD, Penno KL, Brzezinski JL. Identification of Microorganisms Isolated From Counterfeit and Unapproved Decorative Contact Lenses. J Forensic Sci. 2018 Mar;63(2):635-639. doi: 10.1111/1556-4029.13553. Epub 2017 May 24.
  17. Gray, A. How fake handbags fund terrorism and organized crime, Ted Talk. Nov 2017. Available at https://www.ted.com/talks/alastair_gray_how_fake_handbags_fund_terrorism_and_organized_crime?language=en Accessed 31 Oct 2023