ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack.
This recall has been terminated (originally issued April 11, 2019).
- Recall Initiated
- March 11, 2019
- Posted
- April 11, 2019
- Terminated
- December 6, 2021
- Recall Number
- Z-1131-2019
- Quantity
- 300 lenses
- Firm Location
- Jacksonville, FL
- Official Source
- View on FDA website ↗
Reason for Recall
One lot of ACUVUE OASYS for ASTIGMATISM Brand Contact lenses has the potential for a limited number of individual contact lens packages to have an incomplete packaging seal.
Distribution
Distributed to California.
Lot / Code Info
Lot Number on box and individual contact lens package: B00RWF0. UPC: 733905669460
Root Cause
Equipment maintenance
Action Taken
Johnson & Johnson Vision Care, Inc. notified the single distributor on about 03/11/2019 via "URGENT ACTION: VOLUNTARY and LIMITED MEDICAL DEVICE RECALL" letter. The letter instructed the consignee to review their inventory to determine if any affected contact lenses are on hand, stop using all affected lenses, provide the recall notification to anyone within the organization that should be aware of the issue, and notify any customers may have received any affected product and request they discontinue use and return any on hand. They advised the consignee to contact Customer Service at 1-800-843-2020 to arrange for the return and replacement of affected lenses, and they were requested to complete and return the Customer Reply Form.