Recall Z-2916-2018— Johnson & Johnson Vision Care, Inc.

Name: FDA recall Z-2916-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-23

Class II · Terminated

Class II FDA medical device recall by Johnson & Johnson Vision Care, Inc., initiated 2018-07-23, terminated 2021-12-06. It names one FDA 510(k) clearance: K062614. Product: 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.. 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..

Recalling firm: Johnson & Johnson Vision Care, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-07-23
Terminated: 2021-12-06
Firm location: Jacksonville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K062614 — VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY)Johnson & Johnson Vision Care, Inc.·cleared 2006-11-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.