CLASS III Device recall · Reported 2 May 2018 · FDA Enforcement Report
56% 1 Day Silicone Hydrogel (-4.50), UV Blocking recalled
CooperVision is recalling 56% 1 Day Silicone Hydrogel (-4.50), UV Blocking, daily disposable contact lenses The, distributed nationwide in the US. The recall was initiated on 21 Feb 2018 and the FDA has classified it as Class III.
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-1517-2018
- FDA event ID
- 79755
- Recalling firm
- CooperVision, W Henrietta, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 Feb 2018
- FDA classified
- 25 Apr 2018
- Reported
- 2 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Contact Lenses & Eye Devices
Timeline
| 21 Feb 2018 | Recall initiated by company | |
| 25 Apr 2018 | Classified by FDA | +63 days |
| 2 May 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The secondary packaging is labeled with an incorrect expiration date.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dopters that does not interfere with visualacuity. Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UVblocker help protect against transmission of harmful UV radiation to the cornea andinto the eye.
Where it was distributed
US Nationwide Distribution to states of: AL, AR, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY.
Nationwide AlabamaArkansasCaliforniaColoradoFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasKentuckyMarylandMaineMichiganMinnesotaMissouriMississippiNorth CarolinaNebraska
Questions about this recall
Why was it recalled?
The secondary packaging is labeled with an incorrect expiration date.
Which lots are affected?
Lot 14364100237018, Exp. Date 9/30/2020 (foil); 9/30/2022 (carton)
Where was it sold?
US Nationwide Distribution to states of: AL, AR, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
Other products in this recall event
3 other products · FDA event 79755This product is part of a recall event; the main page for the event is clariti 1 day (-1.25), UV Blocking, 90 silicone hydrogel recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | clariti 1 day (-1.25), UV Blocking, 90 silicone hydrogel recalled | CooperVision | Packaging Defects | Nationwide | |
| CLASS III | clariti 1 day/Fresh Day (-1.00), UV Blocking recalled by CooperVision | CooperVision | Packaging Defects | Nationwide | |
| CLASS III | 56% 1 Day Silicone Hydrogel (-2.50), UV Blocking recalled | CooperVision | Packaging Defects | Nationwide |
More recalls from CooperVision
All 34| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pearle Vision 1 day (somofilcon A) Contact Lens recalled by CooperVision | CooperVision | Other | Nationwide |
| 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 |
| Device | CLASS II | Biofinity Toric Multifocal Contact Lens recalled by CooperVision | CooperVision | Packaging Defects | Nationwide |
Other Contact Lenses & Eye Devices recalls
All 153| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pearle Vision 1 day (somofilcon A) Contact Lens recalled by CooperVision | CooperVision | Other | Nationwide |
| 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 |