MyDay toric contact lenses recalled after one lot used invalid sterilization
MyDay Toric contact lenses from one lot are recalled because the lot was manufactured with an invalid sterilization cycle. 4,140 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; an invalid sterilization cycle on a lens worn on the eye is a potential harm and no injuries are reported.
Plain-English summary
MyDay Toric (stenfilcon A) contact lenses, a 54% water content toric cast moulded silicone hydrogel daily disposable lens supplied in blister packs, are being recalled. The affected product carries carton lot number 20735504301008 and blister lot number 6450505898. The recall covers 4,140 units distributed in Florida, Kentucky, North Carolina and Wisconsin.
The recall was issued because one lot was manufactured with an invalid sterilization cycle. The FDA classified the action as Class II.
Eye care practices and wearers holding this lot should stop using the lenses and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
- Manufacturer
- CooperVision, Inc.
- Category
- Medical Device — Contact Lenses
- Affected units
- 4,140
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Carton Lot Number: 20735504301008. Blister Lot Number: 6450505898
Distribution
Part of a larger recall action
This product is one of 3 recalled by CooperVision, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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