Recall Z-1865-2021 ยท LPL Lenses, Soft Contact, Daily Wear
Johnson & Johnson Vision Care, Inc.
ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50
| Date | May 6, 2021 |
| Status | Terminated |
| 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 ne |
| Quantity | 6,780 lenses |
| Distribution | Worldwide Distribution. US nationwide, Canada, Germany, Austria, Belgium, France, Luxemburg, Netherland, Portugal, Spain, Sweden, Switzerland, and Trinidad and Tobago. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160212 | ACUVUE (senofilcon C) Soft Contact Lens Johnson & Johnson Vision Care, Inc., Mar 28, 2016 |