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
- Recall Number
- Z-0808-2021
- Event Number
- 86952
- Firm
- Clerio Vision
- FEI Number
- 3005184723
- Product Code
- LPL
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- December 10, 2020
- Terminated
- July 5, 2023
- Address
- 7575 Commerce Ct, Sarasota, FL, 34243-3218
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.
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
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 [email protected] 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. If you have further distributed this product, please identify your customers and notify them at once of this product recall. You may include this letter in your notification, or you can provide us with your customer list and we will notify them. Physicians/Opticians/Retailers: Please complete the response form at the end of this notice and return by email to [email protected] 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. If you have dispensed this product, please identify your patients/customers and notify them at once of this product recall. You may include this letter in your notification."
US Nationwide distribution.
208 lenses