Recall Z-1131-2019 ยท LPL Lenses, Soft Contact, Daily Wear
Johnson & Johnson Vision Care, Inc.
ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack.
| Date | Apr 11, 2019 (initiated Mar 11, 2019) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Equipment maintenance |
| Action | 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- |
| Quantity | 300 lenses |
| Distribution | Distributed to California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042275 | VISTAKON (SENOFILCON A) SOFT CONTACT LENS Vistakon, Oct 28, 2004 |