Summary
The FDA issued a Class II for 24K Premium Lense, Distributed by Updream Inc. by Ontact Inc. Reason: Contact lenses recalled due to potential bacterial contamination..
Details
Source
Device Recall
External ID
Z-2270-2024
Action Date
2024-07-17
Status
Ongoing
Category
device
Product Description
24K Premium Lense, Distributed by Updream Inc.
Lot/Code Info: All distributed lenses.
Quantity Affected: 2,842
Reason for Recall
Contact lenses recalled due to potential bacterial contamination.
Distribution
US Nationwide distribution in the states of California and Nevada.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-20
Company
Riverside, CA
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 188 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (Ontact Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ontact Inc have FDA actions?
This is the only FDA action we have on record for Ontact Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2270-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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