Recall Z-0808-2021 ยท LPL Lenses, Soft Contact, Daily Wear
Clerio Vision
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 v
| Date | Dec 10, 2020 |
| Status | Terminated |
| 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 |
| Root cause | Process control |
| Action | The firm initiated the recall by letter and email on 12/10/2020. The letter requested the following actions to be taken by the customer: "Distributors: Please immediately examine your inventory, cease all distribution and quarantine this product. Please complete the response form at the end of this notice and return by email to sarasotacustomercare@cleriovision.com even if you no longer have any of the product. Return any inventory via US Mail, marking the package, Attention: Returns Department Recall Product. Your account will be reimbursed for the returned goods and shipping cost. |
| Quantity | 208 lenses |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.