Device product
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.
Z-1352-2021
Product summary
- Firm
- Clerio Vision
- Event
- Event 87421
- Status
- Terminated
- Classification
- Class II
- Quantity
- 153 lenses
- Official record key
device-enforcement:Z-1352-2021
Official wording
Reason: Contact lenses may be mislabeled with the incorrect lens power.
Code information: Lot Number: 0114511565, UPC Code: 675506700657 (6 pack), 675506668650 (individual)
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of Illinois and Missouri, and the countries of Denmark, Germany, The Netherlands, Switzerland.
Derived failure modes
-
Labeling or packaging
mislabeled