Scleral Lens Patient Satisfaction (GSLS Breakfast Talk)
Unsafe scleral lens filling solutions sold on Amazon are putting patients at risk
Aidan Moore, Rebecca Petris, Sandra Brown MD
Dry Eye Foundation, Poulsbo, WA, USA.
PURPOSE
To identify risk factors associated with certain preservative-free (PF) saline solutions marketed to scleral lens users on Amazon.
METHODS
We conducted Amazon searches on September 3, 2025 and December 23, 2025 in incognito browser windows and analyzed the first 25 search results on the term “scleral saline.” For each PF saline solution in the results, we reviewed the Amazon product title, information and images provided by the seller, and quantity purchased within the last month. We purchased and reviewed each product including its package, product insert, and label. We also conducted individual searches for each product brand name. Finally, we obtained copies of the 510(k) for each product with premarket authorization.
RESULTS
We identified 12 PF salines. 6 (50%) had no 510(k). 5 (42%) had a valid 510(k) with an indication for use as a scleral lens insertion solution. 1 (8%) had a 510(k) lacking an indication for scleral lens insertion. 10 (83%) were packaged in single dose or multidose containers manufactured with “Blow-Fill-Seal” technology while 2 (17%) were packaged in multi-dose screw-top bottles. 4 (33%) were marketed only for their approved indications while 8 (67%) made marketing claims outside of their approved indication or did not have a 510(k). Common non-compliant marketing claims were lens cleaning (5 products, 42%) and lens storage (4 products, 33%). Of the products marketed under a 510(k), one is sold on Amazon only by an unauthorized distributor. 47% of total PF saline unit sales on Amazon in August 2025 were of non-compliant products i.e. either products lacking 510(k) premarket authorization (28%) or products marketed in violation of their 510(k) (19%). Searches for product names “Lacripure” “Purilens,” “Scleralfil,” “Tangible Fill,” and “VibrantVue” each returned at least one non-compliant product.
DISCUSSION
In 2025, six new preservative-free saline solutions were listed for sale on Amazon despite lacking FDA 510(k) clearance. Preservative-free saline solutions represent a significant monthly out-of-pocket expense, and some patients may seek low cost alternatives to their provider’s recommended brand. The recall of one popular filling solution in 2025 led to acute shortages for the remaining brands. Unrestricted online sales opportunities, consumer demand for lower cost scleral lens filling solutions, and supply chain issues amongst compliant product manufacturers have created an attractive environment for opportunistic sellers. Manufacturers who do not undergo FDA facility inspections and distributors who fail to seek regulatory clearance for their products cannot provide credible assurance of the sterility of their scleral lens filling solutions.
CONCLUSIONS
Sales of unapproved scleral lens filling solutions have become commonplace on Amazon. Providers may be unaware that their patients are purchasing these salines. Patients who purchase these solutions are at risk of filling sclerals with non-sterile saline. Providers need to educate patients about these risks, recommend specific product brands and review contact lens solution compliance at every visit.
Commercial interests: Rebecca Petris is the owner and Aidan Moore consults to the Dry Eye Company, a retail business with eye and lens care products.