Z-1352-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 14, 2021
- Initiation Date
- February 16, 2021
- Termination Date
- July 5, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 153 lenses
Product Description
EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.
Reason for Recall
Contact lenses may be mislabeled with the incorrect lens power.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of Illinois and Missouri, and the countries of Denmark, Germany, The Netherlands, Switzerland.
Code Information
Lot Number: 0114511565, UPC Code: 675506700657 (6 pack), 675506668650 (individual)