FDA Enforcement
Class II
Terminated
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.
Recall: Z-1352-2021
·
Reported April 14, 2021
Enforcement
- Recall Number
- Z-1352-2021
- Event ID
- 87421
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Clerio Vision
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- April 14, 2021
- Initiation Date
- February 16, 2021
- Classification Date
- April 5, 2021
- Termination Date
- July 5, 2023
- Address
- 7575 Commerce Ct, N/A, Sarasota, FL, 34243-3218, United States
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
Contact lenses may be mislabeled with the incorrect lens power.
Code Info
Lot Number: 0114511565, UPC Code: 675506700657 (6 pack), 675506668650 (individual)
Distribution
Worldwide distribution - US Nationwide distribution in the states of Illinois and Missouri, and the countries of Denmark, Germany, The Netherlands, Switzerland.
Quantity
153 lenses