January 1st 2021 Blog
As a medical professional, your priority is patient retention. When you have patients who suffer from eye discomfort associated with contact lens wearer usage, you should be asking questions about the cases. “Where are my contact lens storage cases manufactured?” and “Does my current vendor have FDA (Food and Drug Administration) 510(k) Clearance assuring its manufacturing and usage safety?”
There may be a correlation between the contact lens wearer and the discomfort they are experiencing. This could have to do with how and where the contact lens storage case was made. Contact lens users may not think about the safety of their contact lens storage cases. There are large amounts of contact lens cases made outside of the USA in countries without FDA 510(k) oversight regulations.
As an example, many of the fake solar eclipse sunglasses were made overseas. These glasses were legal to manufacture off-shore and distribute within in the USA despite not having been approved by the FDA. They did not protect the wearer’s eyes when looking into the sun and left the wearer susceptible to permanent eye damage. USA Today confirmed, “One California man suffered significant vision loss because the glasses he had bought were fake” (Shari, 2017).
It can be a risk to your patient’s eye health unless you are absolutely positive of where the contact lens storage case that you dispensing is manufactured. Many contact lens storage case suppliers acquire their products from overseas manufacturers where the offshore production facility may not operate under the same strict FDA rules and guidelines as Eaton Manufacturing adheres to.
For example, most contact lens storage cases are made using a plastic injection mold release spray which helps to improve the speed of production. The oils contained within mold release sprays can permeate the contact lens case material which can cause leaching of the mold release spray silicone oil into the contact lens as it soaks over time. This leaching effect could be a contributing factor to contact lens wearer discomfort and program dropouts. If a contact lens patient complains about eye dryness, itchiness, or irritation due to their contact lenses, despite having followed all of the doctor’s instruction concerning the care of their lenses, then it may be reasonable to question how that contact lens storage case was manufactured and under what conditions.
Chemical contamination of the materials used to produce the contact lens storage case may be a lesser known cause. Leached plastic contaminants such as BPA (bisphenol A) can be absorbed by the contact lens when stored in the lens case over time and consequently be absorbed by the patient’s corneal tissue when worn. BPA is a chemical found in some resins and plastics which has been linked to many health issues. According to The Mayo Clinic, “Exposure to BPA is a concern because of possible health effects of BPA on the brain, behavior and prostate gland of fetuses, infants and children. Additional research suggests a possible link between BPA and increased blood pressure” (Dr. Bauer 2016). Another common concern is whether products contain toxins or other known cancer-causing carcinogens such as cadmium. The Agency for Toxic Substances and Disease Registry published a list determining cadmium as the seventh most toxic metal with extensive commercial use (Izatt, 2017).
An important proactive solution in avoiding contact lens wearer discomfort is the frequent changing of the contact lens storage case. Bacteria can quickly build up in the contact lens storage case and may also contribute to the cause of various eye infections, which may reduce a patient’s ability to wear contact lenses in the future. Contact lens microbial keratitis can be linked to unhygienic contact lens cases where microbes inevitably contaminate the case and bacterial colonization find its way to the lens and consequently the patient’s eye. One way to avoid bacterial transfer is to switch to a new contact lens storage case as frequently as every 30 days.
The good news is you can help your patients avoid contact lens wearer discomfort and reduce contact lens program dropouts by adhering to the following criteria. First, the lens storage case should be manufactured with Approved FDA Grade sourced materials by a company with a 510(k) Compliance Certification obtained from the USA FDA allowing for manufacturing and commercial distribution of the product in the USA.
Secondly, the manufacturer must assure that NO Silicone and/or mold release spray is used during the manufacturing process. Contact Lens Spectrum Magazine found wearer dropout is highly correlated to the products used with contact lenses; “Because most of the contact lens problems we solve relate to lens care products and compliance, it’s important to tell patients how critical it is to maintain their contact lenses properly with care products that will ensure years of safe and comfortable wear” (André, 2004).
Eaton Manufacturing offers “made in the USA” Flat Pack, Mailer, Flip Top, and Deep Well Contact Lens Storage Cases that are FDA Grade, BPA Free (bisphenol A) and Silicone Free.
For more information and bulk pricing options please call:
Toll Free (800) 253-5949 I Direct (901) 274-0000 I FAX (901) 274-4500
Eaton Manufacturing Corporation