MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.
FDA device recall Z-1014-2023 · posted 2023-01-24 · Open, Classified
Recall details
- Recalling firm
- CooperVision, Inc.
- Reason for recall
- Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- LPL
- Quantity affected
- 6,570 lenses
- Distribution
- Distribution to US states of CA, FL, IA, KY, NC, NY, OH, OR, WI; Canada and Japan.
- Date initiated
- 2022-12-27
- Date posted
- 2023-01-24
- Location
- West Henrietta, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SUS (STENFILCON A) CONTACT LENS (K131378) | CooperVision, Inc. | 2013-08-30 |