Recall Z-1865-2021— Johnson & Johnson Vision Care, Inc.
Class II · Terminated
Class II FDA medical device recall by Johnson & Johnson Vision Care, Inc., initiated 2021-05-06, terminated 2021-11-02. It names one FDA 510(k) clearance: K160212. Product: ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50. Reason: Potential that a limited number of individual contact lens packages have an incomplete packaging seal..
- Recalling firm
- Johnson & Johnson Vision Care, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-05-06
- Terminated
- 2021-11-02
- Firm location
- Jacksonville, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50
Reason for recall
Potential that a limited number of individual contact lens packages have an incomplete packaging seal.
Data sourced from openFDA. This site is unofficial and independent of the FDA.