SAFETY ALERT: 0.9% sodium chloride solution sold by 3N
The Dry Eye Foundation is warning consumers against the following product for any use, whether in the eye or for use with any contact lens or contact lens cleaning device.
0.9% sodium chloride solution sold by 3N
Reasons for concern:
STERILITY NOT GUARANTEED. The manufacturer does not state that the product is sterile. The manufacturing facility is unknown and not inspected by the FDA.
NOT REGISTERED WITH FDA: This solution does not have a 510k device registration with the FDA, a requirement for all sterile contact lens solutions.
NOT CLEARED FOR ADVERTISED USE. “3N Eyecare” is selling this solution for use with their ReO2 series of contact lens cleaning devices. However, the 3N device which has FDA clearance for contact lens cleaning requires that the device be used with either OptiFree Express Multi-Purpose Disinfecting Solution or ReNu MultiPlus Multi-Purpose Solution, not with any preservative-free saline solution.
From fda.gov - 510k #K211361
From 3neyecare.com
Misleading reviews
Reviews on the manufacturer’s website, if authentic, suggest it is being used as an eyewash and as a filling solution for scleral lenses.
