SKBM Microkeratome cutting tool
FDA device recall Z-0612-03 · posted 2003-03-06 · Terminated
Recall details
- Recalling firm
- Alcon Laboratories, Inc
- Reason for recall
- Degradation of glue causes glass movement resulting in misalignment that can cause deeper cuts than anticipated.
- Action taken
- Customers have been notified in writing of this recall action (11/18/2002), and instructed to return all SKBM and/or Lasitome microkeratome products. All returned product will be physically segregated and dispositioned by Alcon. Recall Effectiveness checks will be attempted between 10%-100% of the consignees.
- Root cause
- Other
- Status
- Terminated
- Product code
- HNO
- Quantity affected
- 567
- Distribution
- Distribution was nationwide and to the following foreign countries: Spain, Taiwan, UK, Mexico, Brazil, India, France, Ireland, China, Lebanon, Germany, Australia, Italy, Saudi Arabia, Greece, Japan, N
- Date initiated
- 2002-11-18
- Date posted
- 2003-03-06
- Date terminated
- 2003-07-08
- Location
- Fort Worth, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SUMMIT KRUMEICH-BARRAQUER MICROKERATOME (K980675) | Summit Technology, Inc. | 1998-12-22 |