CLASS II ONGOING Device recall · Reported 30 Sep 2026 · FDA Enforcement Report
Pearle Vision 1 day (somofilcon A) Contact Lens recalled by CooperVision
CooperVision is recalling Pearle Vision 1 day (somofilcon A) Contact Lens, distributed nationwide in the US. The recall was initiated on 12 Aug 2026 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-3248-2026
- FDA event ID
- 99766
- Recalling firm
- CooperVision, West Henrietta, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Aug 2026
- FDA classified
- 18 Sep 2026
- Reported
- 30 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Contact Lenses & Eye Devices
Timeline
| 12 Aug 2026 | Recall initiated by company | |
| 18 Sep 2026 | Classified by FDA | +37 days |
| 30 Sep 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A small number of lenses within the affected lot are of the incorrect power.
Product as listed by the FDA
Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day
Where it was distributed
US Nationwide distribution in the states of MN, OH, WI.
Questions about this recall
Why was it recalled?
A small number of lenses within the affected lot are of the incorrect power.
Which lots are affected?
Pearle Vision 1 day; Carton Lot # 11727620152030; Blister Lot # CB132348;
Where was it sold?
US Nationwide distribution in the states of MN, OH, WI.
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 6 Oct 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 |
| 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 |
| Device | CLASS II | Biofinity XR Toric 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 | 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 |