Food, drugs, devices › CooperVision, Inc.

Device recall: MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.

FDA enforcement event 91389 · Class II · initiated 27 Dec 2022 · status Ongoing

DeviceVoluntary: Firm initiated1 product recordWest Henrietta, NY

FDA enforcement event 91389 is a device recall by CooperVision, Inc. of West Henrietta, NY, initiated 27 Dec 2022 and classified Class II, with 1 product record.

FDA defines Class II as 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. 88% of the 839 device enforcement events initiated in 2022 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. CooperVision, Inc. has 12 enforcement events on this register, with a median of 2 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

CooperVision, Inc., West Henrietta, NY.

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."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1014-2023	MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.	6,570 lenses	Class II	Ongoing	1 Feb 2023

Context

88%of 2022 device events are Class II839 events that year

1product record in this eventfirm median: 2

12events on this register for the firm

Other enforcement events for CooperVision, Inc.

Initiated	Product (first record)	Type	Class	Records
22 Aug 2025	MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silic	Device	Class II	3
16 Jun 2025	Biofinity XR Toric Contact Lens	Device	Class II	2
27 Feb 2025	Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1	Device	Class II	1
29 Aug 2024	BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with asti	Device	Class II	2
14 Feb 2023	Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90	Device	Class II	1
26 Jan 2023	Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)	Device	Class II	2
19 May 2021	CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker	Device	Class II	12
13 Jan 2020	Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended wear)	Device	Class II	2
21 Feb 2018	clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, daily disposable contact lenses The Clariti 1	Device	Class III	4
1 Sep 2017	Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are	Device	Class III	1

All 12 events for CooperVision, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Where was the product distributed?

FDA's distribution pattern field reads: "Distribution to US states of CA, FL, IA, KY, NC, NY, OH, OR, WI; Canada and Japan."

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.