ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR
FDA Recall Z-1210-2018 · Posted None
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Recalling FirmJohnson & Johnson Vision Care, Inc.
Recall StatusTerminated
Product CodeLPL
Date Initiated2017-10-19
Date Terminated2020-06-12
Product Quantity165,750
Reason for Recall
Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
Firm Action
On October 19, 2017, Johnson and Johnson sent letters to their customers stating the recall of ACUVUE and given the instructions to review their inventory, stop using the affected lots, use the enclosed label to return any affected products, contact customer service to arrange the return, even if they do not have any recall product inventory. A contact was provided to each individual letter.
Root Cause
Packaging process control
Distribution Pattern
Worldwide distribution. US nationwide including Puerto Rico, Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil
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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