Recall Z-2144-2021
CooperVision Inc. · initiated May 19, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
Codes / lots: Lot Number: R0121629
Reason for recall
Misaligned placement of an axis mark can cause the patient to experience blurred vision
FDA-determined 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.
Details
- Recall number
- Z-2144-2021
- Initiated
- May 19, 2021
- Terminated
- March 13, 2023
- Product code
- LPL – Lenses, Soft Contact, Daily Wear
- Quantity
- 720 lenses
- 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.
- Recalling firm
- CooperVision Inc., West Henrietta, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2143-2021 Class II | CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blockerMisaligned placement of an axis mark can cause the patient to experience blurred vision | 05/19/2021Terminated |
| Z-2145-2021 Class II | FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable Contact Lens with UV blockerMisaligned placement of an axis mark can cause the patient to experience blurred vision | 05/19/2021Terminated |
| Z-2146-2021 Class II | CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blockerMisaligned placement of an axis mark can cause the patient to experience blurred vision | 05/19/2021Terminated |
| Z-2147-2021 Class II | CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blockerMisaligned placement of an axis mark can cause the patient to experience blurred vision | 05/19/2021Terminated |
| Z-2148-2021 Class II | SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV…Misaligned placement of an axis mark can cause the patient to experience blurred vision | 05/19/2021Terminated |
| Z-2149-2021 Class II | CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact Lens with…Misaligned placement of an axis mark can cause the patient to experience blurred vision | 05/19/2021Terminated |
| Z-2150-2021 Class II | CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blockerMisaligned placement of an axis mark can cause the patient to experience blurred vision | 05/19/2021Terminated |
| Z-2151-2021 Class II | MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV…Misaligned placement of an axis mark can cause the patient to experience blurred vision | 05/19/2021Terminated |
| Z-2152-2021 Class II | CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blockerMisaligned placement of an axis mark can cause the patient to experience blurred vision | 05/19/2021Terminated |
| Z-2153-2021 Class II | FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blockerMisaligned placement of an axis mark can cause the patient to experience blurred vision | 05/19/2021Terminated |
| Z-2154-2021 Class II | SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with…Misaligned placement of an axis mark can cause the patient to experience blurred vision | 05/19/2021Terminated |