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U.S. Department of Health and Human Services

Class 2 Device Recall Alcon

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  Class 2 Device Recall Alcon see related information
Date Initiated by Firm February 15, 2011
Date Posted April 12, 2011
Recall Status1 Terminated 3 on October 02, 2012
Recall Number Z-1842-2011
Recall Event ID 58076
Product Classification ophthalmic laser - Product Code HQF
Product Alcon 3000LE ophthalmic laser
Code Information Units manufactured between August 2007 and 20 February 2011.
Recalling Firm/
Manufacturer		 Ellex Medical Pty Ltd
82 Gilbert Street
Adelaide Australia
Manufacturer Reason
for Recall		 Unintended laser emission while the user was moving the joystick for targeting.
FDA Determined
Cause 2		 Process control
Action Ellex notified all distributors that have received the affected devices per Global Customer Service Bulletin GSB-11 -01a, dated 25 February 2011.
Quantity in Commerce 416 units
Distribution worldwide distribution
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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