ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive P...
FDA Recall #Z-1744-2020 — Class II — December 18, 2017
Product Description
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.
Recalling Firm
Johnson & Johnson Vision Care, Inc. — Jacksonville, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
150 lenses.
Distribution
Nationwide US.
Code Information
Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated