Alcon Laboratories, Inc. LADARVision Excimer Laser System. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LADARVision Excimer Laser System.
Brand
Alcon Laboratories, Inc.
Lot Codes / Batch Numbers
CustomCornea software only. System serial numbers with prefix L4N and L4U.
Products Sold
CustomCornea software only. System serial numbers with prefix L4N and L4U.
Alcon Laboratories, Inc. is recalling LADARVision Excimer Laser System. due to Alcon has identified a software error associated with the use of the Measuring Mode (ruler tool) on the LADARVision4000 Excimer Laser Systems. Use of. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
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 noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026