MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wea...
FDA Recall #Z-1014-2023 — Class II — December 27, 2022
Product Description
MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.
Reason for Recall
Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.
Recalling Firm
CooperVision, Inc. — West Henrietta, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
6,570 lenses
Distribution
Distribution to US states of CA, FL, IA, KY, NC, NY, OH, OR, WI; Canada and Japan.
Code Information
Lot 6474502034 - packaged into 2 packaging lots: 21514501939036, 21514501972036 No UDI
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated