FDA Medical Device Recalls (openFDA)
Johnson & Johnson Vision Care, Inc.: ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50
- Recall number
- Z-1865-2021
- 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
- Status
- Terminated
- Initiated
- 2021-05-06
- Posted
- not on file
- Terminated
- 2021-11-02
- Reason
- Potential that a limited number of individual contact lens packages have an incomplete packaging seal.
- 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 vpiweb@visus.jnj.com, 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
- 6,780 lenses
- Distribution
- Worldwide Distribution. US nationwide, Canada, Germany, Austria, Belgium, France, Luxemburg, Netherland, Portugal, Spain, Sweden, Switzerland, and Trinidad and Tobago.
- Lot, serial or model codes
- UPC 733905989612 LOT # BOOWWWL
- 510(k) numbers
- ["K160212"]
- PMA numbers
- not on file
- Product code
- LPL
- Firm FEI
- 1000222023
- Firm city
- Jacksonville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28