''Alcon Ladarwave CustomCornea Wavefront System'' Aberrometer software Version 7.91
FDA Recall Z-1078-03 · Posted 2003-08-06
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Recalling FirmAlcon Laboratories, Inc.
Recall StatusTerminated
Date Initiated2003-07-21
Date Terminated2010-01-20
Product Quantity157
Reason for Recall
Software error could, under specific circumstances, allow the patient's centration images and data to be stored incorrectly.
Firm Action
The firm mailed their 'Urgent Medical Device Safety Alert' letters to health care professtionals on July 21, 2003 along with a response form. The letter alerts the user to the problem and also how to assure that no erroneous data was saved. The letter also states that a Service Representative will be visiting to install a corrective software version 7.93. The version was completed at the start of the recall and service representative visits to install the software upgrade began approximately 7/22/03.
Root Cause
Other
Distribution Pattern
109 U.S. customers and 48 international device locations. There were 12 devices on-hand.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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