Class 2 Device Recall Extreme H2O 59 Xtra

• Date Initiated by Firm: February 16, 2021
• Create Date: April 05, 2021
• Recall Status: Terminated on July 05, 2023
• Recall Number: Z-1352-2021
• Recall Event ID: 87421
• Product Classification: Lenses, soft contact, daily wear - Product Code LPL
• 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.
• Code Information: Lot Number: 0114511565, UPC Code: 675506700657 (6 pack), 675506668650 (individual)
• Recalling Firm/ Manufacturer: Clerio Vision; 7575 Commerce Ct; Sarasota FL 34243-3218
• For Additional Information Contact: Michelle Perkins, Vice-President; 941-739-1382
• Manufacturer Reason for Recall: Contact lenses may be mislabeled with the incorrect lens power.
• FDA Determined 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 customers identify and notify any customers the affected product was further distributed to.
• Quantity in Commerce: 153 lenses
• Distribution: Worldwide distribution - US Nationwide distribution in the states of Illinois and Missouri, and the countries of Denmark, Germany, The Netherlands, Switzerland.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.