Recall Z-1209-2018— Johnson & Johnson Vision Care, Inc.

Name: FDA recall Z-1209-2018
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: K042275. Product: ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS. 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

K042275 — VISTAKON (SENOFILCON A) SOFT CONTACT LENSVistakon·cleared 2004-10-28

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 OASYS Brand Contact Lenses with HYDRACLEAR PLUS

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.