MyDay Toric and Reveal 1 Day Toric Contact Lenses Recalled for Incorrect Power
CooperVision is recalling MyDay Toric and Reveal 1 Day Toric contact lenses because some may have incorrect power, resulting in poor visual acuity. Consumers using affected lots should stop wearing the lenses and consult their eye care provider.
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: This is an FDA Class II recall of contact lenses with potentially incorrect optical power that could affect vision. No illnesses or injuries have been reported. The product poses a risk of harm to wearers who may experience poor visual acuity, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
CooperVision, Inc. is recalling certain batches of MyDay Toric (90-pack) and Reveal 1 Day Toric (90-pack) soft contact lenses for daily wear and single use. The recalled lenses are from Lot 6474502034, which was packaged into lots 21514501939036 and 21514501972036.
Some of the affected contact lenses may have incorrect optical power. A patient using such a lens may experience poor visual acuity.
The recalled lenses were distributed in California, Florida, Iowa, Kentucky, North Carolina, New York, Ohio, Oregon, and Wisconsin, as well as Canada and Japan.
If you are using contact lenses from the affected packaging lots, you should stop wearing them immediately and contact your eye care provider for a replacement. Verify your prescription before using any new lenses.
The recalled product
- Product
- MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.
- Manufacturer
- CooperVision, Inc.
- Category
- Medical Device — Contact Lens
- Affected units
- 6,570
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 (2)
- Lot 6474502034 - packaged into 2 packaging lots: 21514501939036
- 21514501972036 No UDI
Distribution
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