FDA Medical Device Recalls (openFDA)
CooperVision, Inc.: MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.
- Recall number
- Z-1014-2023
- Recalling firm
- CooperVision, Inc.
- Product
- MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.
- Status
- Open, Classified
- Initiated
- 2022-12-27
- Posted
- 2023-01-24
- Terminated
- not on file
- Reason
- Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 6,570 lenses
- Distribution
- Distribution to US states of CA, FL, IA, KY, NC, NY, OH, OR, WI; Canada and Japan.
- Lot, serial or model codes
- Lot 6474502034 - packaged into 2 packaging lots: 21514501939036, 21514501972036 No UDI
- 510(k) numbers
- ["K131378"]
- PMA numbers
- not on file
- Product code
- LPL
- Firm FEI
- 3005724763
- Firm city
- West Henrietta
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28