FDA recall Z-1744-2020

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

Product

ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.

Reason for recall

Package integrity failure observed during routine shift package integrity testing at an external re-packager.

Distribution

Nationwide US.

Key facts

Status
Terminated
Initiation date
2017-12-18
Report date
2020-04-29
Termination date
2020-06-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Jacksonville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1744-2020