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U.S. Department of Health and Human Services

Class 2 Device Recall Sofmed Breathables

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 Class 2 Device Recall Sofmed Breathablessee related information
Date Initiated by FirmAugust 22, 2025
Date PostedSeptember 19, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2607-2025
Recall Event ID 97515
510(K)NumberK131378 K190965 K220070 
Product Classification Lens, contact, (disposable) - Product Code MVN
ProductSofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
Code Information Carton Lot Number: 20735504301008. Blister Lot Number: 6450505898
Recalling Firm/
Manufacturer		 CooperVision, Inc.
180 Thruway Park Dr
West Henrietta NY 14586-9798
For Additional Information ContactAnnette Nelson
1-925-6604471
Manufacturer Reason
for Recall		One lot manufactured with an invalid sterilization cycle.
FDA Determined
Cause 2		Under Investigation by firm
ActionCooperVision contacted consignees via telephone call and letter on 08/27/2025. Consignees were instructed to examine inventory and quarantine affected lot numbers, cease further distribution of product, and notify customers/patients if further distributed. Consignees were also requested to complete and return the Correction Response Form and arrange for the return of affected units.
Quantity in Commerce180 units
DistributionUS Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.
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 = MVN
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