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
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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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