The Recall Desk
HighFDA (Devices)·Z-0030-2022·Announced 2021-10-13

Contact Lens Solution Recalled for Possible Foreign Material Contamination

Contamac Solutions is recalling Nutrifill Scleral, Hybrid, and GP Lens Insertion Solution nationwide due to potential foreign material contamination. The solution is used to insert contact lenses and was distributed to all U.S. states and Washington, DC.

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: FDA Class II medical device with risk-of-harm potential (foreign material in eye-contact product). No illnesses or injuries have been reported, so per the rubric, maximum score is 3.

Plain-English summary

Contamac Solutions, Inc. is recalling Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free. The product is supplied in 35 single-use 10ml ampoules (UDI: 00850012123002, Lot FOE) and is used to insert contact lenses onto the eye.

The recall was initiated because the solution may contain foreign material. Since this product is applied directly to the eye during lens insertion, any foreign material could pose a risk to eye health.

The product was distributed nationwide to all U.S. states and Washington, DC. Approximately 104,335 vials were affected by this recall.

Consumers who have this product should stop using it. If you have used this product and experience any eye symptoms such as discomfort, redness, or irritation, consult your eye care provider.

The recalled product

Product
Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002
Manufacturer
Contamac Solutions, Inc.
Hazard
  • foreign-material

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 (1)

  • Lot Number: FOE

Distribution

Distributed nationwide across the United States.