Device product
MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.
Z-1014-2023
Product summary
- Event
- Event 91389
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6,570 lenses
- Official record key
device-enforcement:Z-1014-2023
Official wording
Reason: Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.
Code information: Lot 6474502034 - packaged into 2 packaging lots: 21514501939036, 21514501972036 No UDI
Distribution pattern: Distribution to US states of CA, FL, IA, KY, NC, NY, OH, OR, WI; Canada and Japan.
Derived failure modes
-
Unknown
Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.