1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses. The Vistakon (etafilcon A) Soft (hydrophilic) C

FDA device recall Z-1335-2013 · posted 2013-05-17 · Terminated

Recall details

Recalling firm

Johnson & Johnson Vision Care, Inc.

Reason for recall

Limited number of individual contact lens packages may not have been completely sealed.

Action taken

The firm, Johnson & Johnson, Vision Care, Inc. sent a letter dated January 9, 2013 to all their consignees stating the following actions: " Please contact your patients that may have received any of the affected product and instruct them to discontinue use immediately and return product to you for replacement " Please return the enclosed Business Reply Card (BRCl confirming for our records that you have received this notice, and indicating whether or not you have in stock, or have distributed to patients, any product from the lots noted above. " Please return any remaining affected product in your possession using the enclosed pre-paid mailer. " Pass this notice on to anyone in your practice that needs to be informed " Customer service will arrange for the return and replacement of any affected product. If you have any questions and/or if replacement lenses are needed, please contact customer Service (1-800-87 4-5278).

Root cause

Packaging

Status

Terminated

Product code

LPL

Quantity affected

36,330 lenses

Distribution

Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and Puerto Rico; an

Date initiated

2012-12-21

Date posted

2013-05-17

Date terminated

2013-07-05

Location

Jacksonville, FL

Related 510(k) clearances