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U.S. Department of Health and Human Services

Class 2 Device Recall extreme H2O monthly

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  Class 2 Device Recall extreme H2O monthly see related information
Date Initiated by Firm December 10, 2020
Create Date January 08, 2021
Recall Status1 Open3, Classified
Recall Number Z-0808-2021
Recall Event ID 86952
Product Classification Lenses, soft contact, daily wear - Product Code LPL
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.
Code Information LOT 3100246509, EXP 2026/09
Recalling Firm/
Manufacturer
Clerio Vision
7575 Commerce Ct
Sarasota FL 34243-3218
For Additional Information Contact Michelle Perkins
941-739-1382
Manufacturer 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
FDA Determined
Cause 2
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. 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 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. 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."
Quantity in Commerce 208 lenses
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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