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.
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: 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
- Affected units
- 104,335
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
Related recalls
Same manufacturer · Contamac Solutions, Inc.
See all →- HighContact Lens Insertion Solution Recalled for Potential Sterility Defect
FDA (Devices) · 2025-06-18
Same hazard · foreign material
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- ModerateSo Delicious Dairy Free Salted Caramel Cluster Cashewmilk Recalled for Foreign Material
FDA (Food) · 2026-09-30
- HighWindstone Medical Packaging Recalls AMS Convenience Kits Due to Foreign Material
FDA (Devices) · 2026-09-16
- ModerateGolden State Medical Supply Recalls Carbamazepine Tablets Due to CGMP Deviations
FDA (Drugs) · 2026-08-26
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
Similar recalls
- HighContact Lens Insertion Solution Recalled for Potential Sterility Defect
FDA (Devices) · 2025-06-18
- HighFDA Recalls Neostigmine Methylsulfate Injectable Due to Contamination Risk
FDA (Drugs) · 2022-08-24
- HighMoxifloxacin Ophthalmic Injection Solution Recalled for Glass Particle Contamination
FDA (Drugs) · 2024-03-06
- SevereAscorbic Acid Injection Recalled Nationwide for Glass Contamination
FDA (Drugs) · 2024-11-13
- SevereUS Compounding Recalls Phenylephrine Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- ModerateAllergan Recalls Refresh Contacts Comfort Drops Due to Missing Instructions
FDA (Devices) · 2021-02-10