Z-1744-2020Class II

ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power...

Name: Z-1744-2020 ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power...
Creator: Johnson & Johnson Vision Care, Inc.
Published: 2017-12-18
License: https://open.fda.gov/license/

Johnson & Johnson Vision Care, Inc. / initiated 2017-12-18 / Terminated / root cause: packaging

FDA source

Johnson & Johnson Vision Care, Inc. began a recall of ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90 on 2017-12-18. FDA classified it as Class II and gives the reason as "Package integrity failure observed during routine shift package integrity testing at an external re-packager". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1744-2020
Classification: Class II
Status: Terminated
Initiated: 2017-12-18
Posted: 2020-04-17
Terminated: 2020-06-10
Recalling firm: Johnson & Johnson Vision Care, Inc.
Product: ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.
Product code: MVN Lens, Contact, (Disposable)
Reason for recall: Package integrity failure observed during routine shift package integrity testing at an external re-packager.
Root cause tag: packaging
FDA root cause: Packaging
Action: Johnson & 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.
Quantity in commerce: 150 lenses.
Distribution: Nationwide US.
Product codes and lots: Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1744-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1744-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-17

Product code MVN

K042275Class IIVistakon (Senofilcon a) Soft Contact LensVistakon / cleared 2004-10-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)