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U.S. Department of Health and Human Services

Class 1 Device Recall ReNu with MoistureLoc, Bausch & Lomb

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  Class 1 Device Recall ReNu with MoistureLoc, Bausch & Lomb see related information
Date Initiated by Firm April 13, 2006
Date Posted August 31, 2006
Recall Status1 Terminated 3 on September 17, 2012
Recall Number Z-1201-06
Recall Event ID 35176
510(K)Number K033854  K051755  
Product Classification contact lens solution - Product Code LPN
Product Bausch & Lomb * ReNu¿ with MoistureLoc¿, Multi-purpose soft contact lens solution * Sterile * Manufactured by: Bausch & Lomb, Rochester, NY 14609.
Code Information All lots, all sizes
Recalling Firm/
Manufacturer		 Bausch & Lomb
350 Market Street
Rochester NY 14692
For Additional Information Contact Doug Fortunato
585-338-5477
Manufacturer Reason
for Recall		 Reports of Fusarium Infections among contact lens wearers.
FDA Determined
Cause 2		 Component design/selection
Action Press release was issued 4/13/2006. Letters were sent via blast email to retailers, Pharmacists and Eye Care Practitioners on 04/14/2006.
Quantity in Commerce 3 million units
Distribution Worldwide, including USA, Latin America, and Asia
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.
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