Z-2270-2024Class II

24K Premium Lense, Distributed by Updream Inc

Name: Z-2270-2024 24K Premium Lense, Distributed by Updream Inc
Creator: Ontact Inc
Published: 2024-03-20
License: https://open.fda.gov/license/

Ontact Inc / initiated 2024-03-20 / Open, Classified / root cause: manufacturing process

FDA source

Ontact Inc began a recall of 24K Premium Lense, Distributed by Updream Inc on 2024-03-20. FDA classified it as Class II and gives the reason as "Contact lenses recalled due to potential bacterial contamination". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2270-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-20
Posted: 2024-07-05
Recalling firm: Ontact Inc
Product: 24K Premium Lense, Distributed by Updream Inc.
Product code: MVN Lens, Contact, (Disposable)
Reason for recall: Contact lenses recalled due to potential bacterial contamination.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 3/20/24, the firm started visiting consignees, verbally notifying them of the recall, and collecting remaining product.
Quantity in commerce: 2,842
Distribution: US Nationwide distribution in the states of California and Nevada.
Product codes and lots: All distributed lenses.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2270-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2270-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-05

Product code MVN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)