Z-1210-2018Class II

ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR

Name: Z-1210-2018 ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR
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 ADVANCE Brand Contact Lenses with HYDRACLEAR 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-1210-2018
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 ADVANCE Brand Contact Lenses with HYDRACLEAR
Product code: LPL Lenses, Soft Contact, Daily 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: 165,750
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 B00DHLP Exp. 08/2018 Base Curve 8.7, Refractive Power -10.00D - Manufactured in J&J Vision Care Inc. Jacksonville, FL Lot L002FNL Exp. 07/2020 Base Curve 8.7 Refractive Power -4.75D Manufactured in J&J Vision Care Ireland Lot L002V94 Exp. 01/2022 Base Curve 8.7 Refractive Power -5.00D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1210-2018
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 LPL

K032340Class IIVistakon (Galyfilcon a) Soft Contact LensJohnson & Johnson Vision Care, Inc. / cleared 2003-10-16

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)