Recall Z-2150-2021— CooperVision Inc.
Class II · Terminated
Class II FDA medical device recall by CooperVision Inc., initiated 2021-05-19, terminated 2023-03-13. It names one FDA 510(k) clearance: K130331. Product: CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker. Reason: Misaligned placement of an axis mark can cause the patient to experience blurred vision.
- Recalling firm
- CooperVision Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-05-19
- Terminated
- 2023-03-13
- Firm location
- West Henrietta, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
Reason for recall
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Data sourced from openFDA. This site is unofficial and independent of the FDA.