Recall Z-1014-2023— CooperVision, Inc.

Name: FDA recall Z-1014-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-27

Class II · Ongoing

Class II FDA medical device recall by CooperVision, Inc., initiated 2022-12-27. It names one FDA 510(k) clearance: K131378. Product: MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.. Reason: Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity..

Recalling firm: CooperVision, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-12-27
Firm location: West Henrietta, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K131378 — SUS (STENFILCON A) CONTACT LENSCooperVision, Inc.·cleared 2013-08-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.