Recall Z-1744-2020— Johnson & Johnson Vision Care, Inc.

Name: FDA recall Z-1744-2020
Creator: U.S. Food and Drug Administration
Published: 2017-12-18

Class II · Terminated

Class II FDA medical device recall by Johnson & Johnson Vision Care, Inc., initiated 2017-12-18, terminated 2020-06-10. It names one FDA 510(k) clearance: K042275. Product: ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.. Reason: Package integrity failure observed during routine shift package integrity testing at an external re-packager..

Recalling firm: Johnson & Johnson Vision Care, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-12-18
Terminated: 2020-06-10
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 for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.

Reason for recall

Package integrity failure observed during routine shift package integrity testing at an external re-packager.

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