Recall Z-1352-2021 ยท LPL Lenses, Soft Contact, Daily Wear
Clerio Vision
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.
| Date | Feb 16, 2021 |
| Status | Terminated |
| Reason | Contact lenses may be mislabeled with the incorrect lens power. |
| Root cause | Process control |
| Action | Customers were contacted by phone on 02/16/2021 and instructed to segregate and return product with the affected lot number. An URGENT MEDICAL DEVICE RECALL were sent to impacted customers by standard USPS first class mail beginning on 03/03/2021. Customers are instructed to examine their inventory, cease all distribution and quarantine affected product, and complete and return by email the response form included with the recall notice. Customers are to return any affected inventory via US Mail, marking the package, Attention: Returns Department Recall Product. The letter instructs custome |
| Quantity | 153 lenses |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of Illinois and Missouri, and the countries of Denmark, Germany, The Netherlands, Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.