Recall Z-1131-2019— Johnson & Johnson Vision Care, Inc.
Class II · Terminated
Class II FDA medical device recall by Johnson & Johnson Vision Care, Inc., initiated 2019-03-11, terminated 2021-12-06. It names one FDA 510(k) clearance: K042275. Product: ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack.. Reason: 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..
- Recalling firm
- Johnson & Johnson Vision Care, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-11
- Terminated
- 2021-12-06
- 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 OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.