''Alcon Ladarwave CustomCornea Wavefront System'' Aberrometer software Version 7.91
FDA device recall Z-1078-03 · posted 2003-08-06 · Terminated
Recall details
- Recalling firm
- Alcon Laboratories, Inc.
- Reason for recall
- Software error could, under specific circumstances, allow the patient's centration images and data to be stored incorrectly.
- Action taken
- 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
- Status
- Terminated
- Quantity affected
- 157
- Distribution
- 109 U.S. customers and 48 international device locations. There were 12 devices on-hand.
- Date initiated
- 2003-07-21
- Date posted
- 2003-08-06
- Date terminated
- 2010-01-20
- Location
- Orlando, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM (K023249) | Alcon Laboratories, Inc. | 2002-10-18 |