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:
NO COMPANY IDENTIFIED: Per Amazon, this product is made in China, but the box does not state where the product is made, or the name and contact information of the company distributing it, or who to contact if there are any problems.
STERILITY NOT GUARANTEED: While the product claims to be sterile, the manufacturer of this product is completely unknown and not inspected by FDA.
NOT REGISTERED WITH FDA: Lulrsay Preservative Free Saline does not have a 510k device registration with the FDA, a requirement for all sterile contact lens solutions.
We are in contact with Amazon and the FDA about these issues.
Why is DEF concerned about sterility?
DEF is on on heightened alert for the safety of all preservative-free eye drops and solutions manufactured in questionable facilities, due to a major increase in the incidence of contaminated solutions and FDA warnings to manufacturing facilities about failure to follow protocols for sterile (“aseptic”) manufacturing.
We have no information to help determine whether this product is correctly manufactured.
It appears to be a 0.9% sodium chloride solution sold in the domestic Chinese market as an inhalation solution but then repackaged and relabeled by scammers.
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.”
The pH claim is false. According to the label, Lulrsay contains no buffering agents, only sodium chloride and water.
The cleansing and storage claims are false. 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 is 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.