Recall Z-2916-2018 ยท LPL Lenses, Soft Contact, Daily Wear
Johnson & Johnson Vision Care, Inc.
Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve, -3.25 Power. Master Lot, containing 12 split lots, repackaged in 30 and 90-packs . Intended for daily disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
| Date | Jul 23, 2018 |
| Status | Terminated |
| Reason | Johnson and Johnson Vision Care received a number of reports of a partially formed contact lens, which appears to the customer or consumer as visibly smaller in diameter, thicker/stiffer to the touch and more darkly tinted blue than the normal contact lens. |
| Root cause | Equipment maintenance |
| Action | On July 23, 2018, the Johnson & Johnson notified customers of the recall via an "URGENT FIELD SAFETY NOTICE" letter date July 23, 2018. The letter to US and international customers included the following instructions: review inventory and determine if any affected product is on hand, cease using any affected product, provide the recall notification to anyone within the organization who needs to be aware of the recall, return any affected product and arrange for replacement product, and complete and return the enclosed Customer Reply Form. The distributor notification included a copy of th |
| Quantity | 195,660 Total; 89,640 US & Puerto Rico, 106,020 OUS |
| Distribution | Worldwide distribution: US (Nationwide) distribution to CA, CT, FL, GA, IA, IL, MA, MD, ME, MO, NC, NE, NH, NJ, NY, OH, PA, TN, TX, UT, and VA, Puerto Rico; and countries of: Canada, Barbados, Japan, and Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062614 | VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) Johnson & Johnson Vision Care, Inc., Nov 1, 2006 |