Recall Z-1211-2018— Johnson & Johnson Vision Care, Inc.

Name: FDA recall Z-1211-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-19

Class II · Terminated

Class II FDA medical device recall by Johnson & Johnson Vision Care, Inc., initiated 2017-10-19, terminated 2020-06-12. It names one FDA 510(k) clearance: K051900. Product: 1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses. Reason: Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil..

Recalling firm: Johnson & Johnson Vision Care, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-10-19
Terminated: 2020-06-12
Firm location: Jacksonville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K051900 — ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEARJohnson & Johnson Vision Care, Inc.·cleared 2005-08-12

K-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

1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses

Reason for recall

Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.

Data sourced from openFDA. This site is unofficial and independent of the FDA.