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Terminated

1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses

FDA Recall Z-1211-2018 · Posted None

Recalling FirmJohnson & Johnson Vision Care, Inc.
Recall StatusTerminated
Product CodeMVN
Date Initiated2017-10-19
Date Terminated2020-06-12
Product Quantity56,070

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.

K051900ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEARJohnson & Johnson Vision Care, Inc. · 2005-08-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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