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U.S. Department of Health and Human Services

Class 2 Device Recall MyDay Toric; Reveal 1 Day Toric

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  Class 2 Device Recall MyDay Toric; Reveal 1 Day Toric see related information
Date Initiated by Firm December 27, 2022
Date Posted January 24, 2023
Recall Status1 Open3, Classified
Recall Number Z-1014-2023
Recall Event ID 91389
510(K)Number K131378  
Product Classification Lenses, soft contact, daily wear - Product Code LPL
Product MyDay 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 Contact Customer 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
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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LPL and Original Applicant = COOPERVISION, INC.
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