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U.S. Department of Health and Human Services

Class 1 Device Recall LADAR6000

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 Class 1 Device Recall LADAR6000see related information
Date Initiated by FirmFebruary 21, 2007
Date PostedJune 05, 2007
Recall Status1 Terminated 3 on March 21, 2017
Recall NumberZ-0854-2007
Recall Event ID 37605
PMA NumberP970043 
Product Classification Excimer Laser System - Product Code LZS
ProductLADAR6000 Excimer Laser System
Code Information All serial/lot numbers of the LADAR6000
Recalling Firm/
Manufacturer		 Alcon Refractive Horizons, Inc.
2800 Discovery Dr
Orlando FL 32826-3010
Manufacturer Reason
for Recall		Observed 'central islands' in patients following custom myopia laser procedures using the LADAR6000 Excimer Laser. (On May 11, 2007, Alcon notified consignees that the device software programs for CustomCornea Myopia and CustomCornea Myopia with Astigmatism of the device would be deactivated)
FDA Determined
Cause 2		Other
ActionConsignees were notified of the recall via two letters. On Feb. 21, 2007, consignees were requested to immediately stop performing all custom cornea myopia procedures and to return an acknowledgement card indicating they have received the alert and understand the required actions. On May 11, 2007, Alcon notified consignees that the device software programs for CustomCornea Myopia and CustomCornea Myopia with Astigmatism of the device would be deactivated. After meeting with CDRH's Office of Compliance on August 27, 2007, the recalling firm committed to total product removal of the device. Notification will begin in Sept 2007 and will be made by personal visits to each consignee.
Quantity in Commerce102
DistributionWorldwide Distribution-including USA, Czech Republic, Spain, Australia, Italy, Hong Kong, Vietnam, Singapore, South Korea, and Canada
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = LZS
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