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U.S. Department of Health and Human Services

Class 2 Device Recall OOptix (lotrafilcon B) Soft Contact Lenses

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  Class 2 Device Recall OOptix (lotrafilcon B) Soft Contact Lenses see related information
Date Initiated by Firm January 11, 2007
Date Posting Updated February 15, 2007
Recall Status1 Terminated 3 on March 21, 2008
Recall Number Z-0427-2007
Recall Event ID 37113
510(K)Number K033919  
Product Classification Soft Contact Lenses - Product Code LPM
Product O¿Optix¿ (lotrafilcon B) Soft Contact Lenses, Rx only, Ciba Vision. The product is distributed in 3 packs (3 lenses per package) and 6 packs (6 lenses per package).
Code Information All Lots starting with 6644001 through 6721262, with expiration dating of 2011/09 through 2011/11, and Lot numbers: 6626127, 6636101, 637017, 6637019, 6637103, 6640120, 6640124, 6642109, 6642119, 6642132 and 6643080, all with expiration dating of 2011/08.
Recalling Firm/
Manufacturer
Ciba Vision Corporation
11460 Johns Creek Pkwy
Duluth GA 30097-1518
For Additional Information Contact CIBA Vision Customer Service
800-241-5999
Manufacturer Reason
for Recall
Reduced Ion Permeability
FDA Determined
Cause 2
Other
Action Consignees were notified by traceable mail on 01/12/2007. Consignees were advised to locate any of the affected lots and return them to CIBA Vision in accordance with the attached instructions. Returned lenses will be destroyed.
Quantity in Commerce 11.4 million lenses
Distribution Worldwide, Including USA, Canada, Australia, Benelux, UK and Germany
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 = LPM and Original Applicant = CIBA VISION CORPORATION
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