Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ACUVU E OASYS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall ACUVU E OASYS see related information
Date Initiated by Firm December 18, 2017
Create Date April 17, 2020
Recall Status1 Terminated 3 on June 10, 2020
Recall Number Z-1744-2020
Recall Event ID 85261
510(K)Number K042275  
Product Classification Lens, contact, (disposable) - Product Code MVN
Product ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.
Code Information Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.
Recalling Firm/
Manufacturer		 Johnson & Johnson Vision Care, Inc.
7500 Centurion Pkwy
Jacksonville FL 32256-0517
For Additional Information Contact Abdiel Alvarez
904-443-3794
Manufacturer Reason
for Recall		 Package integrity failure observed during routine shift package integrity testing at an external re-packager.
FDA Determined
Cause 2		 Packaging
Action Johnson & Johnson Vision Care Inc., notified customers on 12/18/2017 via Recall Notification letter. Included with the Recall Notification Letter was a Customer Reply Form which the customer is instructed to fax back to the firm.
Quantity in Commerce 150 lenses.
Distribution Nationwide US.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MVN and Original Applicant = VISTAKON
-
-