Alcon Laboratories, Inc.
''Alcon Ladarwave CustomCornea Wavefront System'' Aberrometer software Version 7.91
| Date | Aug 6, 2003 (initiated Jul 21, 2003) |
| Status | Terminated |
| Reason | Software error could, under specific circumstances, allow the patient's centration images and data to be stored incorrectly. |
| Root cause | Other |
| 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. |
| Quantity | 157 |
| Distribution | 109 U.S. customers and 48 international device locations. There were 12 devices on-hand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023249 | ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM Alcon Laboratories, Inc., Oct 18, 2002 |