Safety Alert: Do Not Use Aqua Naina Sterile Saline Solution
The Dry Eye Foundation is warning consumers against the following product for use with any contact lenses, including scleral lenses:
Aqua Naina Sterile Saline Solution
Reasons for concern:
NOT STERILE: The closure system for Aqua Naina bottles is faulty. The lid can be removed and replaced without removing the safety seal. (See video below). There is evidence that bottles are leaking prior to delivery.
NOT SAFE FOR ADVERTISED USE: This solution has FDA clearance only for rinsing lenses just before you put them in your eye (after you have disinfected them with a disinfection solution). However, Aqua Naina is being advertised on Walmart for “cleaning, rinsing and storage,” and on Amazon for “cleaning, rinsing and disinfection.” Using a preservative-free saline solution to store contact lenses is a known risk factor for acanthamoeba keratitis, an extremely serious eye infection.
We are in contact with the manufacturer and the FDA about these issues.
Why is DEF concerned about sterility?
DEF has received multiple reports of leaking bottles and wet shipping boxes. DEF ordered its own bottle from Amazon and identified salt crusting on the exterior of the bottle and water stains on the box.
Our investigation shows it is possible to remove the bottle cap without removing the tamper resistant shrink seal, meaning the product is potentially non-sterile.
Why is DEF concerned about Aqua Naina advertising?
Aqua Naina saline solution is a multi-dose non-preserved buffered saline solution (ingredients: purified water, sodium chloride, boric acid, and sodium borate) which is being marketed for contact lens cleaning, disinfection and storage.
Aqua Naina cannot clean nor disinfect, and is unsafe for storage as it does not contain ingredients which inhibit bacterial growth.
According to reviews, scleral lens users are using Aqua Naina to fill their lenses
Don’t be fooled
Federal law prohibits products with a 510(K) from being advertised as FDA Approved. According to 21 C.F.R. § 807.97 “any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.”