CLASS II ONGOING Device recall · Reported 1 Feb 2023 · FDA Enforcement Report
MyDay Toric Reveal 1 Day Toric Soft recalled by CooperVision
CooperVision is recalling MyDay Toric Reveal 1 Day Toric Soft (hydrophilic) Contact Lens (daily wear), distributed in 9 states. The recall was initiated on 27 Dec 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1014-2023
- FDA event ID
- 91389
- Recalling firm
- CooperVision, West Henrietta, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Dec 2022
- FDA classified
- 24 Jan 2023
- Reported
- 1 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Contact Lenses & Eye Devices
Timeline
| 27 Dec 2022 | Recall initiated by company | |
| 24 Jan 2023 | Classified by FDA | +28 days |
| 1 Feb 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.
Product as listed by the FDA
MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.
Where it was distributed
Distribution to US states of CA, FL, IA, KY, NC, NY, OH, OR, WI; Canada and Japan.
CaliforniaFloridaIowaKentuckyNorth CarolinaNew YorkOhioOregonWisconsin
Questions about this recall
Why was it recalled?
Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.
Which lots are affected?
Lot 6474502034 - packaged into 2 packaging lots: 21514501939036, 21514501972036 No UDI
Where was it sold?
Distribution to US states of CA, FL, IA, KY, NC, NY, OH, OR, WI; Canada and Japan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from CooperVision
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|---|---|---|---|---|---|
| Device | CLASS II | Sofmed Breathables, (stenfilcon A) contact lens recalled by CooperVision | CooperVision | Sterility | Nationwide |
| Device | CLASS II | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled | CooperVision | Sterility | Nationwide |
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| Device | CLASS II | Biofinity Toric Multifocal Contact Lens recalled by CooperVision | CooperVision | Packaging Defects | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System recalled | AMO Puerto Rico Manufacturing | Device Malfunction | Nationwide |
| Device | CLASS II | Alcon PRECISION1 One-Day Contact Lenses, -2.25D recalled | Alcon Research | Sterility | 19 states |
| Device | CLASS II | Sofmed Breathables, (stenfilcon A) contact lens recalled by CooperVision | CooperVision | Sterility | Nationwide |
| Device | CLASS II | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled | CooperVision | Sterility | Nationwide |
| Device | CLASS II | MyDay Toric, stenfilcon A) Contact Lens recalled by CooperVision | CooperVision | Sterility | Nationwide |