FDA Enforcement
Class II
Terminated
CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
Recall: Z-2152-2021
·
Reported August 4, 2021
Enforcement
- Recall Number
- Z-2152-2021
- Event ID
- 88096
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- CooperVision Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 4, 2021
- Initiation Date
- May 19, 2021
- Classification Date
- July 27, 2021
- Termination Date
- March 13, 2023
- Address
- 180 Thruway Park Dr, N/A, West Henrietta, NY, 14586-9798, United States
Description
CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
Reason
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Code Info
Lot Number: W0106186
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.
Quantity
450 lenses