FDA recall Z-1014-2023

CooperVision, Inc. · Class II · device

Product

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.

Distribution

Distribution to US states of CA, FL, IA, KY, NC, NY, OH, OR, WI; Canada and Japan.

Key facts

Status
Ongoing
Initiation date
2022-12-27
Report date
2023-02-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
West Henrietta, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1014-2023