FDA recall Z-1865-2021

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

Product

ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50

Reason for recall

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.

Key facts

Status: Terminated
Initiation date: 2021-05-06
Report date: 2021-06-23
Termination date: 2021-11-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Jacksonville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1865-2021