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U.S. Department of Health and Human Services

Class 2 Device Recall ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS

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 Class 2 Device Recall ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUSsee related information
Date Initiated by FirmOctober 19, 2017
Create DateMarch 27, 2018
Recall Status1 Terminated 3 on June 12, 2020
Recall NumberZ-1209-2018
Recall Event ID 79152
510(K)NumberK042275 
PMA NumberP040045 
Product Classification Lenses, soft contact, extended wear - Product Code LPM
ProductACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS
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
Recalling Firm/
Manufacturer		 Johnson & Johnson Vision Care, Inc.
7500 Centurion Pkwy
Jacksonville FL 32256-0517
For Additional Information Contact
904-443-1000
Manufacturer Reason
for Recall		Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
FDA Determined
Cause 2		Packaging process control
ActionOn October 19, 2017, Johnson and Johnson sent letters to their customers stating the recall of ACUVUE and given the instructions to review their inventory, stop using the affected lots, use the enclosed label to return any affected products, contact customer service to arrange the return, even if they do not have any recall product inventory. A contact was provided to each individual letter.
Quantity in Commerce125,763
DistributionWorldwide distribution. US nationwide including Puerto Rico, Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LPM
PMA DatabasePMAs with Product Code = LPM
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