Public Notice – Contamac Solutions, Inc. Recalls Lot FOE of Nutrifill in the United States On July 27th, 2021, Contamac Solutions, Inc. announced a voluntary product recall in the United States for lot FOE of Nutrifill, a preservative-free contact lens insertion solution. Contamac Solutions, Inc. elected to voluntarily conduct this recall following notification from its third-party manufacturer and out of an abundance of caution due to the identification of isolated black particulates in vials from lot FOE prior to distribution. There have been no customer reports or adverse events related to this issue. This product recall does not affect other batches or lots of Nutrifill. Contamac Solutions, Inc. is working closely with the United States Food and Drug Administration on this voluntary recall. PLEASE SEE THE RESOURCES PAGE FOR THE FULL RECALL PUBLIC NOTICE
for Specialty Contact Lenses
Nutrifill is a preservative free lens insertion solution specifically designed for scleral lens wearers and the wearers of hybrid and gas permeable contact lenses. It has been physiologically formulated to mimic your body’s natural tears.
Contains: sodium, phosphate, potassium, calcium, and magnesium. All essential ions found in our tears.
Manufactured in the USA!
Nutrifill is a patented formulation designed to mimic your body’s essential tears.
Along with the 5 natural electrolytes to help contribute to a healthier ocular environment as you wear your lenses, Nutrifill also has a pH (7.4) and osmolality (300) to simulate the natural tear.
The only FDA cleared insertion solution containing the 4 additional electrolytes (calcium, magnesium, potassium, and phosphate).
Your tears have normal levels of the essential electrolytes; sodium, potassium, calcium, and magnesium along with the phosphate. The environment under the scleral lens provides little to no tear-exchange for many hours and it is believed that using strictly sodium electrolytes can potentially provide stress on the corneal epithelial cells. Nutrifill is designed to minimize that potential stress on the cornea.
Most of the nutrients and essential ions supplied to the cornea are supplied by the tears because they are not supplied through the circulatory system directly. In the case of a scleral lens the reservoir under the lens does not allow for tear exchange (the process of liquid under the lenses being replaced by new tears) as often as it does in other contact lenses. In soft lenses it is measured at approximately 30 minutes. In the case of a scleral lens the exchange rate is often measured in hours. This raises the question what should be done to provide the best environment for scleral lenses.
Nutrifill was designed to provide a solution to go under the lens and provide the essential ions supplied to the cornea by our natural tears. We believe that including the essential ions of sodium, potassium, calcium, and magnesium buffered with phosphate in the scleral lens insertion solution offers patients the benefit of a more natural tear-like solution compared to the current use of sodium chloride solutions alone, especially when you consider that the tear exchange with a scleral lens is often several hours, if not all day.
-Ralph P. Stone, PhD
Inventor, US Patent# 9,259,437
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