Recall Z-1210-2018— Johnson & Johnson Vision Care, Inc.

Name: FDA recall Z-1210-2018
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: K032340. Product: ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR. 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

K032340 — VISTAKON (GALYFILCON A) SOFT CONTACT LENSJohnson & Johnson Vision Care, Inc.·cleared 2003-10-16

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

ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR

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.