Z-1209-2018Class II

ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS

Name: Z-1209-2018 ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS
Creator: Johnson & Johnson Vision Care, Inc.
Published: 2017-10-19
License: https://open.fda.gov/license/

Johnson & Johnson Vision Care, Inc. / initiated 2017-10-19 / Terminated / root cause: packaging

FDA source

Johnson & Johnson Vision Care, Inc. began a recall of ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS on 2017-10-19. FDA classified it as Class II and gives the reason as "Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil". 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-1209-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-19
Posted: 2018-03-27
Terminated: 2020-06-12
Recalling firm: Johnson & Johnson Vision Care, Inc.
Product: ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS
Product code: LPM Lenses, Soft Contact, Extended Wear
Reason for recall: Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: On October 19, 2017, Johnson and Johnson sent letters to their customers stating the recall of ACUVUE and given the instructions to review their inventory, stop using the affected lots, use the enclosed label to return any affected products, contact customer service to arrange the return, even if they do not have any recall product inventory. A contact was provided to each individual letter.
Quantity in commerce: 125,763
Distribution: Worldwide distribution. US nationwide including Puerto Rico, Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil
Product codes and lots: Lot L002NCS exp. 05/2020 base Curve 8.8 Refractive Power -4.00D and Lot L002QH9 exp. 08/2020 Base Curve 8.8 Refractive Power -4.50D Manufactured at J&J Vision Care Ireland

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1209-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1209-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27
Z-1210-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27
Z-1211-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27

Product code LPM

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)