Recall Z-0612-03 ยท HNO Keratome, Ac-Powered
Alcon Laboratories, Inc
SKBM Microkeratome cutting tool
| Date | Mar 6, 2003 (initiated Nov 18, 2002) |
| Status | Terminated |
| Reason | Degradation of glue causes glass movement resulting in misalignment that can cause deeper cuts than anticipated. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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, Netherland, Turkey, Korea, Romania, Latvia, Belgium, Switzerland, Malaysia, Thailand, Portugal, Phi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980675 | SUMMIT KRUMEICH-BARRAQUER MICROKERATOME Summit Technology, Inc., Dec 22, 1998 |