ClearanceBrief
Recall Z-1744-2020 ยท MVN Lens, Contact, (Disposable)

Johnson & Johnson Vision Care, Inc.

ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.

DateDec 18, 2017
StatusTerminated
ReasonPackage integrity failure observed during routine shift package integrity testing at an external re-packager.
Root causePackaging
ActionJohnson & Johnson Vision Care Inc., notified customers on 12/18/2017 via Recall Notification letter. Included with the Recall Notification Letter was a Customer Reply Form which the customer is instructed to fax back to the firm.
Quantity150 lenses.
DistributionNationwide US.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K042275VISTAKON (SENOFILCON A) SOFT CONTACT LENS
Vistakon, Oct 28, 2004