ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack.

FDA device recall Z-1131-2019 · posted 2019-04-11 · Terminated

Recall details

Recalling firm

Johnson & Johnson Vision Care, Inc.

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.

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.

Root cause

Equipment maintenance

Status

Terminated

Product code

LPL

Quantity affected

300 lenses

Distribution

Distributed to California.

Date initiated

2019-03-11

Date posted

2019-04-11

Date terminated

2021-12-06

Location

Jacksonville, FL

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