Recall Z-1352-2021— Clerio Vision
Class II · Terminated
Class II FDA medical device recall by Clerio Vision, initiated 2021-02-16, terminated 2023-07-05. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Contact lenses may be mislabeled with the incorrect lens power..
- Recalling firm
- Clerio Vision
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-02-16
- Terminated
- 2023-07-05
- Firm location
- Sarasota, FL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.