Z-1014-2023Class II

MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use

Name: Z-1014-2023 MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use
Creator: CooperVision, Inc.
Published: 2022-12-27
License: https://open.fda.gov/license/

CooperVision, Inc. / initiated 2022-12-27 / Open, Classified / root cause: manufacturing process

FDA source

CooperVision, Inc. began a recall of MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use on 2022-12-27. FDA classified it as Class II and gives the reason as "Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1014-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-27
Posted: 2023-01-24
Recalling firm: CooperVision, Inc.
Product: MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.
Root cause tag: manufacturing process
FDA 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 in commerce: 6,570 lenses
Distribution: Distribution to US states of CA, FL, IA, KY, NC, NY, OH, OR, WI; Canada and Japan.
Product codes and lots: Lot 6474502034 - packaged into 2 packaging lots: 21514501939036, 21514501972036 No UDI

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1014-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1014-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-01	2023-01-24

Product code LPL

K131378Class IISus (Stenfilcon a) Contact LensCooperVision, Inc. / cleared 2013-08-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)