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Recall Observatory FDA recall evidence

Device product

ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR

Z-1210-2018

October 19, 2017

Class II

Product summary

Firm
Johnson & Johnson Vision Care, Inc.
Event
Event 79152
Status
Terminated
Classification
Class II
Quantity
165,750
Official record key
device-enforcement:Z-1210-2018

Official wording

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

Code information: Lot B00DHLP Exp. 08/2018 Base Curve 8.7, Refractive Power -10.00D - Manufactured in J&J Vision Care Inc. Jacksonville, FL Lot L002FNL Exp. 07/2020 Base Curve 8.7 Refractive Power -4.75D Manufactured in J&J Vision Care Ireland Lot L002V94 Exp. 01/2022 Base Curve 8.7 Refractive Power -5.00D

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