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U.S. Department of Health and Human Services

Class 1 Device Recall LADAR6000

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 Class 1 Recall
LADAR6000
see related information
Date Posted June 05, 2007
Recall Status1 Open
Recall Number Z-0854-2007
Recall Event ID 37605
Premarket Approval
PMA Number
P970043
Product Classification Excimer Laser System - Product Code LZS
Product LADAR6000 Excimer Laser System
Code Information All serial/lot numbers of the LADAR6000
Recalling Firm/
Manufacturer
Alcon Refractive Horizons, Inc.
2800 Discovery Dr
Orlando, Florida 32826-3010
Consumer Instructions Contact the recalling firm for information
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/UNDETERMINED: Under Investigation by the firm
Action Consignees 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 Commerce 102
Distribution Worldwide Distribution-including USA, Czech Republic, Spain, Australia, Italy, Hong Kong, Vietnam, Singapore, South Korea, and Canada
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LZS and Applicant = ALCON LABORATORIES
PMAs with Product Code = LZS and Applicant = ALCON LABORATORIES, INC.
PMAs with Product Code = LZS and Applicant = ALCON LABORATORIES,INC
PMAs with Product Code = LZS and Applicant = ALCON UNIVERSAL, LTD.
PMAs with Product Code = LZS and Applicant = SUMMAUTO
PMAs with Product Code = LZS and Applicant = SUMMIT AUTONOMOUS, INC.
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