SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with UV blocker
This recall has been terminated (originally issued May 19, 2021).
- Company
- Coopervision Inc.
- Recall Initiated
- May 19, 2021
- Terminated
- March 13, 2023
- Recall Number
- Z-2154-2021
- Quantity
- 90 lenses
- Firm Location
- West Henrietta, NY
- Official Source
- View on FDA website ↗
Reason for Recall
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Distribution
Worldwide distribution - US Nationwide distribution in the states of FL, NY, TN, OH, NC, WI and the countries of France, United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, Canada.
Lot / Code Info
Lot Number: W0106167
Root Cause
Equipment maintenance
Action Taken
Coopervision issued Urgent Medical Device Correction letter on 5/19/21 to wholesale/distributor and Eye Care Practitioner level. The independent accounts via overnight FedEx (receipt tracking). Distributors and corporate accounts via email, with a read receipt. Letter states reason for recall, health risk and action to take: Examine your inventory for the affected lot numbers on the enclosed Ship Report. " Stop any further distribution of the specified lots of clariti 1 day toric lenses. " Dispose of the product and, within the next five (5) business days, please complete the attached Correction Response Form and fax it to 866-484-1048 or scan and email to: info@coopervision.com. Your account will be credited once the form is received. If you have any further questions, please feel free to contact CooperVision Customer Service at 800-341-2020, 9:00 AM 7:00 PM ET, Monday Friday.