Recall Z-1014-2023
CooperVision, Inc. · initiated December 27, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.
Codes / lots: Lot 6474502034 - packaged into 2 packaging lots: 21514501939036, 21514501972036 No UDI
Reason for recall
Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.
FDA-determined cause: Process control
Action taken
On December 27, 2022, the firm notified affected wholesale/distributor and Eye Care Practitioner consignees via Urgent Medical Device Correction letters. Customers were instructed to stop any further distribution of product from affected lot numbers and dispose of any affected product still in inventory. Customers may also return product. Customers who are affected by this recall are eligible for credit or replacement. Distributors and Eye Care Practitioners should also contact downstream Eye Care Practitioner customers as well as patients who have received product from the affected lots. Patients with questions may contact CooperVision's Customer Service team at 800-341-2020, 9:00 AM 7:00 PM ET, Monday Friday, or they can visit CooperVision s website at coopervision.com/our-company/contact-us/complaint.
Details
- Recall number
- Z-1014-2023
- Initiated
- December 27, 2022
- Posted by FDA
- January 24, 2023
- Product code
- LPL – Lenses, Soft Contact, Daily Wear
- Quantity
- 6,570 lenses
- Distribution
- Distribution to US states of CA, FL, IA, KY, NC, NY, OH, OR, WI; Canada and Japan.
- Recalling firm
- CooperVision, Inc., West Henrietta, NY