A US study found ‘forever chemicals’, which have been linked to environmental pollution and harmful health effects, in contact lenses made by Acuvue, Alcon and CooperVision.
Testing was commissioned by Mamavation in partnership with Environmental Health News, which identified various levels of organic fluorine, a marker of per- and polyfluroalkyl substances (PFAS), in 18 different soft contact lenses.
Mamavation is a US-based consumer watchdog set up to help women make safer choices for their families and has investigated various grocery products for toxic or hormone-disrupting chemicals.
The contact lenses were sent to a US Environmental Protection Agency-certified lab to test for indications of PFAS and the results found all had varying levels of organic fluorine.
It identified contact lenses that had 1,000 parts per million (ppm) organic fluorine or more, including Acuvue Oasys with HydraLuxe 1-Day (6,096ppm), Alcon Air Optix (no Hydraglide) soft contact lenses for astigmatism (20,000ppm), and CooperVision Biofinity Toric Contact Lenses (4,751ppm).
Mamavation noted that PFAS were likely added to soften contact lenses and allow oxygen to pass through, but it did not know how much PFAS would enter the eye from exposure via contact lenses.
However, Mamavation noted that PFAS have been linked to various health conditions, including increased cholesterol levels, cardiovascular disease and lowered fertility. PFAS resist degradation when used and have been observed to contaminate groundwater, surface water and soil.
A proposal to reduce PFAS emissions into the environment and make products and processes safer is being considered by the European Union’s European Chemicals Agency.
A scientific review of the study was carried out by Linda Birnbaum, scientist emeritus and former director of the National Institute of Environmental Health Sciences and National Toxicology Program and scholar in residence at Duke University, North Carolina University, and Yale University.
‘Your eyes are one of the most sensitive parts of your body. Therefore, it’s concerning to see the presence of organic fluorine, which is likely a type of PFAS, found in all soft contact lens products tested. What about the idea of doing no harm? Do we have proof these products are safe? A lack of safety studies does not qualify as safety, which is what is happening here.’
Safe to wear
The College of Optometrists said it was aware that PFAS have been increasingly detected as a pollutant and were linked to negative effects on human health.
It noted PFAS were used in rigid gas permeable contact lenses in Europe and that its use was under review, including in medical devices.
However, the College said there were not currently any published case reports or formal safety alerts of direct harmful effects relating to PFAS in contact lenses, or peer-reviewed published studies on the release or absorption characteristics of these chemicals from a contact lens to the eye.
The College said in a statement: ‘We recognise the need to reduce the environmental impact of eye care, including contact lens manufacture and disposal, while maintaining the quality and safety of patient care. We would strongly support the research and development of contact lens materials that offer high clinical performance, excellent patient safety and comfort, and environmentally sustainable manufacturing methods.
‘In the meantime, current contact lenses, when worn and cared for according to recommendations by a contact lens practitioner, are considered very safe. Contact lens complications, such as infections, do occur but these are rare, with severe contact lens-related infections affecting two to four people for 10,000 per year with typical daily wear.
‘It is, therefore, important that contact lens wearers attend contact lens appointments as recommended by their practitioner, as this helps ensure their lenses remain suitable, and their eye health can be assessed.’
Regulatory compliance
Euromcontact stated its member companies were committed to reducing the impact of their products on the environment while safeguarding their quality and safety.
‘Contact lenses have been, for decades, demonstrated to be a safe and reliable option for vision correction, providing millions of people worldwide with clear and comfortable sight,’ Euromcontact noted.
The body outlined how the European Union’s extensive regulations regarding medical devices ensured quality and safety because of the rigorous processes contact lenses must go through before being sold.
‘In accordance with European regulations, contact lenses are designed and manufactured with particular attention to the choice of materials and substances used, which have undergone extensive testing to ensure their safety, particularly as regards toxicity. They are designed to be biologically inert, minimising the risk of health issues,’ Euromcontact said.
It added that contact lenses were subject to conformity assessments and independent organisations were commissioned to assess whether medical devices met EU requirements.
‘During the assessment process, the safety of the device is ensured through various means, including testing, clinical evaluation, and post-market surveillance,’ it concluded.
Results questioned
Mamavation said the laboratory it used looked for indications of PFAS because it was ‘simply impossible’ to look directly for PFAS compounds.
It added that all PFAS chemicals were carbon-based compounds that contained fluorine, which was why organic fluorine was looked for as a marker of PFAS. Mamavation noted the type of marker screening it conducted was likely to show the presence of PFAS, as well as other fluorochemicals, non-PFAS fluorine-containing pharmaceuticals, and pesticides.
However, Alcon questioned the results of the report because it said two of its contact lenses, in which the laboratory identified the presence of organic fluorine, did not have organic fluorine in their formulation.
Alcon Total 30 Contact Lenses for Daily Wear was found to have 20,400ppm of organic fluorine and Alcon Dailies Total 1 One-Day Contact Lenses Water Gradient had 625ppm of organic fluorine.
When Optician asked Alcon for comment, the company stated: ‘Alcon contact lenses have been shown to be safe and are used daily by millions of people in more than 140 countries.
‘All of Alcon’s contact lenses meet our stringent internal safety standards and comply with the regulatory requirements of the US Food and Drug Administration, European Chemicals Agency, or similar regulatory bodies in all of the markets in which we sell our products.
‘Alcon continually monitors and evaluates emerging science and information about the materials we use so we can keep earning the trust of the eye care professionals and consumers we serve.
‘We are aware of media coverage of a recent report concerning contact lenses, which purports to measure total organic fluorine in certain contact lenses. Alcon questions the results of that report. For example, Dailies Total 1 and Total 30 contact lenses do not contain organic fluorine in their formulation. Alcon is requesting a copy of the report to better understand how it reached its conclusions.
‘Alcon remains committed to maintaining our legacy of manufacturing contact lenses to the highest quality and safety standards. In the meantime, consumers can confidently use all Alcon contact lenses.’
Johnson & Johnson Vision also said it did not use PFAS in its soft contact lenses when Optician asked for a statement on the report.
Mamavation’s report found Acuvue Oasys with HydraLuxe 1-Day had 6,096ppm of organic fluorine and Acuvue Vita Astigmatism Senofilcon C Brand Contact Lenses had 5,537ppm of organic fluorine.
Johnson & Johnson Vision told Optician: ‘Johnson & Johnson Vision does not use PFAS in our soft contact lenses.’
Optician also asked CooperVision for comment but the company did not provide a statement.