FDA recall Z-1131-2019

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

Product

ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack.

Reason for recall

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.

Key facts

Status: Terminated
Initiation date: 2019-03-11
Report date: 2019-04-17
Termination date: 2021-12-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Jacksonville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1131-2019