FDA Enforcement Class II Ongoing

24K Premium Lense, Distributed by Updream Inc.

Recall: Z-2270-2024 · Reported July 17, 2024

Enforcement

Recall Number
Z-2270-2024
Event ID
94692
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
Ontact Inc
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Visit
Report Date
July 17, 2024
Initiation Date
March 20, 2024
Classification Date
July 5, 2024
Address
10944 Playa Del Sol, N/A, Riverside, CA, 92503-5243, United States

Description

24K Premium Lense, Distributed by Updream Inc.

Reason

Contact lenses recalled due to potential bacterial contamination.

Code Info

All distributed lenses.

Distribution

US Nationwide distribution in the states of California and Nevada.

Quantity

2,842