Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast mo
Summary
The FDA issued a Class II for Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathabl by CooperVision, Inc.. Reason: One lot manufactured with an invalid sterilization cycle..
Details
Source
Device Recall
External ID
Z-2607-2025
Action Date
2025-10-01
Status
Ongoing
Category
device
Product Description
Sofmed 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.
Lot/Code Info: Carton Lot Number: 20735504301008. Blister Lot Number: 6450505898
Quantity Affected: 180 units
Reason for Recall
One lot manufactured with an invalid sterilization cycle.
Distribution
US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-22
Company
West Henrietta, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 152 device recalls issued in the same week, part of 403 device-related FDA actions this month.
CooperVision, Inc. has 27 FDA actions in our database, including 24 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CooperVision, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CooperVision, Inc. have FDA actions?
CooperVision, Inc. has 27 FDA actions in our database, including 24 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2607-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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