Safety Alert: Do Not Use Lulrsay Preservative Free Saline Solution
The Dry Eye Foundation is warning consumers against the following product for use with any contact lenses, including scleral lenses:
Lulrsay Preservative Free Saline Solution
Reasons for concern:
NOT REGISTERED WITH FDA: Lulrsay Preservative Free Saline does not have a 510k device registration with the FDA.
MADE IN CHINA: per Amazon, but box does not state where the product is made, or the name and contact information of the company distributing it.
NO SAFETY OR STERILITY GUARANTEES: The manufacturer of this product is completely unknown and not inspected by FDA.
We are in contact with Amazon and the FDA about these issues.
Why is DEF concerned about sterility?
This product could be manufactured anywhere in the world under unsafe and unsterile conditions. There are no safety guarantees for this product.
At best, this is 0.9% sodium chloride solution sold in the domestic Chinese market repackaged and relabeled by scammers. This product is being distributed without proper FDA registration or inspection.
Considering the last few years' history of problems even with registered facilities, unregistered should always mean "do not use".
This product poses a significant safety risk to scleral lens patients.
Why is DEF concerned about Lulrsay advertising?
Lulrsay claims to be “designed for scleral, soft, and rigid gas permeable (RGP) contacts, this saline solution is buffered to maintain optimal pH levels, ensuring gentle cleansing, rinsing, and safe storage without irritation.”
If the ingredients list on the package is correct, Lulrsday contains only sodium chloride and water. Lulrsay contains no buffering ingredients to raise pH. Lulrsay cannot clean nor disinfect, and is unsafe for storage as it does not contain ingredients which inhibit bacterial growth.
Scammers are running Amazon ads and Lulrsay already appears in search results for “scleral lens filling solution” and “scleral saline”
Product packaging contains numerous spelling errors and are nonsensical in parts. There is no product insert, the country of origin is not listed on the box, and there is no identified manufacturer or distributor.
Use approved brands only
PF sterile manufacturing must be done by experts in inspected facilities.