Contact Lens Insertion Solution Recall Due to Sterility Defect
Contamac Nutrifill contact lens insertion solution may lack sterility, creating an infection risk. Affected lots HFH, HGC, HGI, HGN, HKF, HKK distributed nationwide should not be used.
What this means for you
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: This is an FDA Class II recall of a medical device with a potential sterility defect. No illnesses or injuries have been reported. The hazard—lack of sterility in a contact lens insertion solution—poses a risk of serious eye infections, qualifying as a high-severity risk-of-harm product where injury has not yet been reported.
Plain-English summary
Contamac Solutions, Inc. is recalling Contamac Nutrifill Physiologic formula contact lens insertion solution due to a potential sterility defect. The insertion solution may lack sterility, which could increase the risk of bacterial eye infections.
The recall affects 17,273 cartons containing 604,555 ampoules with lot codes HFH, HGC, HGI, HGN, HKF, and HKK. The product has been distributed nationwide.
Consumers using this product should stop using it immediately and consult their eye care provider. Do not insert contact lenses with a non-sterile solution, as this can cause serious eye infections.
The recalled product
- Product
- Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
- Manufacturer
- Contamac Solutions, Inc.
- Hazard
- sterility-defect
- infection-risk
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
Distributed nationwide across the United States.
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