SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with UV blocker
FDA Recall Z-2154-2021 · Posted None
Recalling FirmCooperVision Inc.
Recall StatusTerminated
Product CodeLPL
Date Initiated2021-05-19
Date Terminated2023-03-13
Product Quantity90 lenses
Reason for Recall
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Firm Action
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: [email protected]. 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.
Root Cause
Equipment maintenance
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.