Recall Record

Jacksonville, FL, United States

Johnson & Johnson Vision Care, Inc. recalls

6 recalls recorded since 2018, most recently on 12 June 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls6
Ongoing (FDA)1
Terminated or completed5
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
12 June 2025
Reason
Due to defects (bubbles/voids) identified during standard finished goods testing
Distribution
Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KN, KS, KY, LA, MA, MD, MI, MO, NC, NJ, NV, NY, OH, PA, SC TN, TX, UT, VA, WA, WI, and WY. The countries of Belgium, Bermuda, Canada, Switzerland, Denmark, Germany, Spain, France, United K
Initiated
Voluntary: Firm initiated
Recall number
Z-2163-2025

Terminated Class II Medical devices

Recall started
6 May 2021
Terminated
2 November 2021
Reason
Potential that a limited number of individual contact lens packages have an incomplete packaging seal.
Distribution
Worldwide Distribution. US nationwide, Canada, Germany, Austria, Belgium, France, Luxemburg, Netherland, Portugal, Spain, Sweden, Switzerland, and Trinidad and Tobago.
Initiated
Voluntary: Firm initiated
Recall number
Z-1865-2021

Terminated Class II Medical devices

Recall started
11 March 2019
Terminated
6 December 2021
Reason
One lot of ACUVUE OASYS¿ for ASTIGMATISM Brand Contact lenses has the potential for a limited number of individual contact lens packages to have an incomplete packaging seal.
Distribution
Distributed to California.
Initiated
Voluntary: Firm initiated
Recall number
Z-1131-2019

Terminated Class II Medical devices

Recall started
23 July 2018
Terminated
6 December 2021
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.
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.
Initiated
Voluntary: Firm initiated
Recall number
Z-2916-2018

Terminated Class II Medical devices

Recall started
18 December 2017
Terminated
10 June 2020
Reason
Package integrity failure observed during routine shift package integrity testing at an external re-packager.
Distribution
Nationwide US.
Initiated
Voluntary: Firm initiated
Recall number
Z-1744-2020

Terminated Class II Medical devices

Recall started
19 October 2017
Terminated
12 June 2020
Reason
Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
Distribution
Worldwide distribution. US nationwide including Puerto Rico, Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1210-2018, Z-1209-2018, Z-1211-2018

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.