Z-1865-2021Class II

ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50

Name: Z-1865-2021 ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50
Creator: Johnson & Johnson Vision Care, Inc.
Published: 2021-05-06
License: https://open.fda.gov/license/

Johnson & Johnson Vision Care, Inc. / initiated 2021-05-06 / Terminated / root cause: manufacturing process

FDA source

Johnson & Johnson Vision Care, Inc. began a recall of ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50 on 2021-05-06. FDA classified it as Class II and gives the reason as "Potential that a limited number of individual contact lens packages 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-1865-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-06
Posted: 2021-06-16
Terminated: 2021-11-02
Recalling firm: Johnson & Johnson Vision Care, Inc.
Product: ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: Potential that a limited number of individual contact lens packages have an incomplete packaging seal.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On May 4th the firm sent a letter to its consignees with the following instructions: Since you have received potentially affected product, please immediately take the following actions: 1. Review your inventory and determine if you have ACUVUE Vita Brand Diagnostic lenses from the impacted lot: B00WWWL 2. STOP using and remove from your inventory all affected product. Note: You can continue to use all other lots not affected by this voluntary recall. 3. Please pass this notice on to anyone in your organization who needs to be aware of the issue and ensure that they maintain awareness as necessary. 4. Please contact your patients that may have received any of the affected product and ask them to discontinue use and return to you for replacement. 5. Customer Service, at 1-800-843-2020, will arrange for you the return and replacement of any affected product. 6. Complete the enclosed Customer Reply Form and return via fax to 904-443-3442 or via email to [email protected], EVEN IF YOU HAVE NO INVENTORY REMAINING affected by this recall. JJVC requires this information for reconciliation purposes with regulatory agencies. The completed Customer Reply Form should be faxed or emailed within 3 business days of receipt of this letter.
Quantity in commerce: 6,780 lenses
Distribution: Worldwide Distribution. US nationwide, Canada, Germany, Austria, Belgium, France, Luxemburg, Netherland, Portugal, Spain, Sweden, Switzerland, and Trinidad and Tobago.
Product codes and lots: UPC 733905989612 LOT # BOOWWWL

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1865-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1865-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16

Product code LPL

K160212Class IIACUVUE (senofilcon C) Soft Contact LensJohnson & Johnson Vision Care, Inc. / cleared 2016-03-28

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)