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Recall Observatory FDA recall evidence

Device product

ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS

Z-1209-2018

October 19, 2017

Class II

Product summary

Firm
Johnson & Johnson Vision Care, Inc.
Event
Event 79152
Status
Terminated
Classification
Class II
Quantity
125,763
Official record key
device-enforcement:Z-1209-2018

Official wording

Reason: Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.

Code information: Lot L002NCS exp. 05/2020 base Curve 8.8 Refractive Power -4.00D and Lot L002QH9 exp. 08/2020 Base Curve 8.8 Refractive Power -4.50D Manufactured at J&J Vision Care Ireland

Distribution pattern: Worldwide distribution. US nationwide including Puerto Rico, Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    foreign matter