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Terminated

LADARVision Excimer Laser System.

FDA Recall Z-1147-06 · Posted 2006-06-21

Recalling FirmAlcon Laboratories, Inc.
Recall StatusTerminated
Product CodeLZS
Date Initiated2005-08-01
Date Terminated2012-07-06
Product Quantity436

Reason for Recall

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.

Firm Action

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.

Root Cause

Other

Distribution Pattern

There have been 285 units distributed in the US and 151 units distributed to International Alcon Affiliates.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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