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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm August 01, 2005
Date Posted June 21, 2006
Recall Status1 Terminated 3 on July 06, 2012
Recall Number Z-1147-06
Recall Event ID 32866
PMA Number P970043 
Product Classification Excimer Laser System - Product Code LZS
Product LADARVision Excimer Laser System.
Code Information CustomCornea software only. System serial numbers with prefix L4N and L4U.
Recalling Firm/
Manufacturer		 Alcon Laboratories, Inc.
2800 Discovery Dr
Orlando FL 32826-3010
Manufacturer Reason
for Recall		 Alcon has identified a software error associated with the use of the Measuring Mode (ruler tool) on the LADARVision4000 Excimer Laser Systems. Use of this feature after alignment of the horizontal reference line will negate compensation for cyclotorsion on CustomCornea procedures, possibly adversely affecting clinical outcomes.
FDA Determined
Cause 2		 Other
Action A Medical Device Safety Alert dated August 1, 2005, has been issued to all consignees. Each consignee was issued a Response To Safety Alert form to acknowledge receipt of the Safety Alert. A Field Service Engineer will visit to install the revised software.
Quantity in Commerce 436
Distribution There have been 285 units distributed in the US and 151 units distributed to International Alcon Affiliates.
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.
PMA Database PMAs with Product Code = LZS and Original Applicant = ALCON LABORATORIES
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