Alcon Refractive Horizons, Inc. LADAR6000 Excimer Laser System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LADAR6000 Excimer Laser System
Brand
Alcon Refractive Horizons, Inc.
Lot Codes / Batch Numbers
All serial/lot numbers of the LADAR6000
Products Sold
All serial/lot numbers of the LADAR6000
Alcon Refractive Horizons, Inc. is recalling LADAR6000 Excimer Laser System due to Observed 'central islands' in patients following custom myopia laser procedures using the LADAR6000 Excimer Laser. (On May 11, 2007, Alcon notified co. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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)
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026