Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MyDay Toric; Reveal 1 Day Toric

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall MyDay Toric; Reveal 1 Day Toricsee related information
Date Initiated by FirmDecember 27, 2022
Date PostedJanuary 24, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1014-2023
Recall Event ID 91389
510(K)NumberK131378 
Product Classification Lenses, soft contact, daily wear - Product Code LPL
ProductMyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.
Code Information Lot 6474502034 - packaged into 2 packaging lots: 21514501939036, 21514501972036 No UDI
Recalling Firm/
Manufacturer		 CooperVision, Inc.
180 Thruway Park Dr
West Henrietta NY 14586-9798
For Additional Information ContactCustomer Service
800-341-2020
Manufacturer 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 2		Process control
ActionOn 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 Commerce6,570 lenses
DistributionDistribution to US states of CA, FL, IA, KY, NC, NY, OH, OR, WI; Canada and Japan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LPL
-
-