ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack.
FDA Recall Z-1131-2019 · Posted 2019-04-11
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Recalling FirmJohnson & Johnson Vision Care, Inc.
Recall StatusTerminated
Product CodeLPL
Date Initiated2019-03-11
Date Terminated2021-12-06
Product Quantity300 lenses
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.
Firm 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 1-800-843-2020 to arrange for the return and replacement of affected lenses, and they were requested to complete and return the Customer Reply Form.
Root Cause
Equipment maintenance
Distribution Pattern
Distributed to California.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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