FDA recall Z-1209-2018

Johnson & Johnson Vision Care, Inc. · Class II · device

Product

ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS

Reason for recall

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

Key facts

Status: Terminated
Initiation date: 2017-10-19
Report date: 2018-04-04
Termination date: 2020-06-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Jacksonville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1209-2018