Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Si
Summary
The FDA issued a Class II for Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physi by Contamac Solutions, Inc.. Reason: Contact lens solution may contain foreign material.
Details
Source
Device Recall
External ID
Z-0030-2022
Action Date
2021-10-13
Status
Terminated
Category
device
Product Description
Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002
Lot/Code Info: Lot Number: FOE
Quantity Affected: 104335 vials
Reason for Recall
Contact lens solution may contain foreign material
Distribution
US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. OUS: N/A
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-27
Company
Grand Junction, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 192 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Contamac Solutions, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Contamac Solutions, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Contamac Solutions, Inc. have FDA actions?
Contamac Solutions, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0030-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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