Recall Z-0808-2021— Clerio Vision
Class II · Terminated
Class II FDA medical device recall by Clerio Vision, initiated 2020-12-10, terminated 2023-07-05. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.
- Recalling firm
- Clerio Vision
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-12-10
- Terminated
- 2023-07-05
- Firm location
- Sarasota, FL, United States
Product 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 for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.