Z-1131-2019Class II

ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6...

Name: Z-1131-2019 ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6...
Creator: Johnson & Johnson Vision Care, Inc.
Published: 2019-03-11
License: https://open.fda.gov/license/

Johnson & Johnson Vision Care, Inc. / initiated 2019-03-11 / Terminated / root cause: manufacturing process

FDA source

Johnson & Johnson Vision Care, Inc. began a recall of ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack on 2019-03-11. FDA classified it as Class II and gives the reason as "One lot of ACUVUE OASYS for ASTIGMATISM Brand Contact lenses has the potential for a limited number of individual contact lens packages to have an incomplete packaging seal". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1131-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-11
Posted: 2019-04-11
Terminated: 2021-12-06
Recalling firm: Johnson & Johnson Vision Care, Inc.
Product: ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack.
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: One lot of ACUVUE OASYS for ASTIGMATISM Brand Contact lenses has the potential for a limited number of individual contact lens packages to have an incomplete packaging seal.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Johnson & Johnson Vision Care, Inc. notified the single distributor on about 03/11/2019 via "URGENT ACTION: VOLUNTARY and LIMITED MEDICAL DEVICE RECALL" letter. The letter instructed the consignee to review their inventory to determine if any affected contact lenses are on hand, stop using all affected lenses, provide the recall notification to anyone within the organization that should be aware of the issue, and notify any customers may have received any affected product and request they discontinue use and return any on hand. They advised the consignee to contact Customer Service at 1-800-843-2020 to arrange for the return and replacement of affected lenses, and they were requested to complete and return the Customer Reply Form.
Quantity in commerce: 300 lenses
Distribution: Distributed to California.
Product codes and lots: Lot Number on box and individual contact lens package: B00RWF0. UPC: 733905669460

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1131-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1131-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-11

Product code LPL

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)