Recall Z-0634-03 ยท HMY Keratome, Battery-Powered
BD Opthalmic Systems
BD K-3000 Microkeratome Blade REF 378607
| Date | Mar 12, 2003 (initiated Jan 24, 2003) |
| Status | Terminated |
| Reason | Microkeratome Blade may cause irregular corneal flap which may delay patients procedure. |
| Root cause | Other |
| Action | BD Ophthalmic notified customers by telephone and email on 1/ 24/03. Users are requested to destroy blades and Certify destruction by returning reply form. |
| Quantity | 1539 Blades |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022637 | BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME Becton, Dickinson & CO, Oct 16, 2002 |