ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50
This recall has been terminated (originally issued May 6, 2021).
- Recall Initiated
- May 6, 2021
- Terminated
- November 2, 2021
- Recall Number
- Z-1865-2021
- Quantity
- 6,780 lenses
- Firm Location
- Jacksonville, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Potential that a limited number of individual contact lens packages have an incomplete packaging seal.
Distribution
Worldwide Distribution. US nationwide, Canada, Germany, Austria, Belgium, France, Luxemburg, Netherland, Portugal, Spain, Sweden, Switzerland, and Trinidad and Tobago.
Lot / Code Info
UPC 733905989612 LOT # BOOWWWL
Root Cause
Process control
Action Taken
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.