Medical Device Recalls

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New Search Back to Search Results   Class 1 Recall LADAR6000 Date Posted June 05, 2007 Recall Number Z-0854-2007 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 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) 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