CLASS II Device recall · Reported 29 Apr 2020 · FDA Enforcement Report
Acuvue Oasys for Astigmatism Contact Lenses recalled
Johnson & Johnson Vision Care is recalling Acuvue Oasys for Astigmatism Contact Lenses, distributed nationwide in the US. The recall was initiated on 18 Dec 2017 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-1744-2020
- FDA event ID
- 85261
- Recalling firm
- Johnson & Johnson Vision Care, Jacksonville, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Dec 2017
- FDA classified
- 17 Apr 2020
- Reported
- 29 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Contact Lenses & Eye Devices
Timeline
| 18 Dec 2017 | Recall initiated by company | |
| 17 Apr 2020 | Classified by FDA | +851 days |
| 29 Apr 2020 | 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
Package integrity failure observed during routine shift package integrity testing at an external re-packager.
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. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.
Where it was distributed
Nationwide US.
Questions about this recall
Why was it recalled?
Package integrity failure observed during routine shift package integrity testing at an external re-packager.
Which lots are affected?
Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.
Where was it sold?
Nationwide US.
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 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 | CA |
| Device | CLASS II | 1-Day Acuvue Moist Daily Wear, 8.5 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 |
Other Contact Lenses & Eye Devices recalls
All 152| 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 |