Recall Z-1021-2007 ยท HNO Keratome, Ac-Powered
Bausch & Lomb Inc
Bausch & Lomb Zyoptix XP Epi Separator, packaged 1 per sterile pouch, 10 per carton, Reorder No. 507-0068, RX, for single use only. Ophthalmic surgical accessory. The product is labeled as Manufactured by: Bausch & Lomb Incorporated, St. Louis, MO. The Epi Separator is used as an accessory to the Zyoptix XP Microkeratome, which is not under recall.
| Date | Aug 2, 2007 (initiated Jun 8, 2007) |
| Status | Terminated |
| Reason | Reports have been received of stromal incursions after use of the product. |
| Root cause | Other |
| Action | The firm notified their customers via telephone between 6/8-12/07. During the call, the customer was informed reports had been received of stromal incursions and they were to quit using the product and return it. |
| Quantity | 243/10-pouch cartons |
| Distribution | Distribution was limited to "key" physicians in MN, SC, MD, and NJ. Foreign distribution was made to the firm's entities in The Netherlands, Singapore, Mexico, Canada, Hong Kong, and India. |
| FDA record | Open on fda.gov |