FDA Enforcement
Class II
Terminated
Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478 (12 count) - Product Usage: for daily wear is 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-0808-2021
·
Reported January 20, 2021
Enforcement
- Recall Number
- Z-0808-2021
- Event ID
- 86952
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Clerio Vision
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- January 20, 2021
- Initiation Date
- December 10, 2020
- Classification Date
- January 8, 2021
- Termination Date
- July 5, 2023
- Address
- 7575 Commerce Ct, N/A, Sarasota, FL, 34243-3218, United States
Description
Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478 (12 count) - Product Usage: for daily wear is 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
One lot of contact lenses labeled as BC MED, DIA 14.0 PWR -2.25 contained BC MED, DIA 14.0, PWR -3.75 contact lenses
Code Info
LOT 3100246509, EXP 2026/09
Distribution
US Nationwide distribution.
Quantity
208 lenses