CLASS II Device recall · Reported 17 Apr 2019 · FDA Enforcement Report
Acuvue Oasys for Astigmatism contact lenses recalled
Johnson & Johnson Vision Care is recalling Acuvue Oasys for Astigmatism contact lenses, Base Curve 6 Refractive Power -1.00D, -1.25D, distributed in California. The recall was initiated on 11 Mar 2019 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-1131-2019
- FDA event ID
- 82402
- Recalling firm
- Johnson & Johnson Vision Care, Jacksonville, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Mar 2019
- FDA classified
- 11 Apr 2019
- Reported
- 17 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Contact Lenses & Eye Devices
Timeline
| 11 Mar 2019 | Recall initiated by company | |
| 11 Apr 2019 | Classified by FDA | +31 days |
| 17 Apr 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
One lot of ACUVUE OASYS¿ for ASTIGMATISM Brand Contact lenses has the potential for a limited number of individual contact lens packages to have an incomplete packaging seal.
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
ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack.
Where it was distributed
Distributed to California.
Questions about this recall
Is Acuvue Oasys for Astigmatism contact lenses, Base Curve 6 Refractive Power -1.00D, -1.25D recalled?
Yes. Johnson & Johnson Vision Care recalled Acuvue Oasys for Astigmatism contact lenses, Base Curve 6 Refractive Power -1.00D, -1.25D on 11 Mar 2019. The recall is Class II and its status is Terminated. Recall number Z-1131-2019.
Why was it recalled?
One lot of ACUVUE OASYS¿ for ASTIGMATISM Brand Contact lenses has the potential for a limited number of individual contact lens packages to have an incomplete packaging seal.
Which lots are affected?
Lot Number on box and individual contact lens package: B00RWF0. UPC: 733905669460
Where was it sold?
Distributed to California.
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 21 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 Johnson & Johnson Vision Care
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Acuvue¿ Oasys Max 1-Day Multifocal recalled | Johnson & Johnson Vision Care | Device Malfunction | Nationwide |
| Device | CLASS II | Acuvue Vita soft (hydrophilic) contact lens (spherical) recalled | Johnson & Johnson Vision Care | Packaging Defects | Nationwide |
| Device | CLASS II | Acuvue Oasys for Astigmatism Contact Lenses recalled | Johnson & Johnson Vision Care | Packaging Defects | Nationwide |
| Device | CLASS II | 1-Day Acuvue Moist Daily Wear, 5 Base Curve, -3.25 Power recalled | Johnson & Johnson Vision Care | Packaging Defects | Nationwide |
| Device | CLASS II | 1-Day Acuvue Moist for Astigmatism Contact Lenses recalled | Johnson & Johnson Vision Care | Foreign Material | Nationwide |
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