Contact Lens Insertion Solution Recalled for Potential Sterility Defect
Contamac Nutrifill Physiologic formula contact lens insertion solution is being recalled because it may lack sterility. The affected product was distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is an FDA Class II device recall for a contact lens solution with a sterility defect. Lack of sterility in an eye-contact product poses a significant risk of microbial contamination and potential eye infection, and no illnesses or injuries are reported in the source text, placing this at the High severity level.
Plain-English summary
Contamac Solutions, Inc. is recalling Contamac Nutrifill Physiologic formula contact lens insertion solution due to a potential lack of sterility. The recall affects 17,273 cartons (604,555 ampoules) with lot codes HFH, HGC, HGI, HGN, HKF, and HKK.
The product was distributed nationwide to the following states: Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Michigan, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Washington, and Wisconsin.
Consumers using this product should stop use immediately and consult their eye care professional if they have any concerns about eye health or symptoms of infection.
The recalled product
- Product
- Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
- Manufacturer
- Contamac Solutions, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- UDI: 00850012123002/ Lot: HFH
- HGC
- HGI
- HGN
- HKF
- HKK
Distribution
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