Recall Z-1022-2007 ยท HNO Keratome, Ac-Powered
Bausch & Lomb Inc
Zyoptix XP Epi Head, packaged 1 per container, Cat. #ZXP32040, packaged nonsterile and reuseable. Ophthalmic surgical accessory. NOTE: The label only names the product as Zyoptix XP Microkeratome. It does not reference the product as an Epi Head The product is labeled as Manufacturer: Bausch & Lomb Incorporated, Rochester, NY. The Epi Head is used as an accessory to the Zyoptix XP Microkerato
| 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 | 29 Epi Heads |
| 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 |
510(k) clearances named in this recall
| K040204 | ZYOPTIX XP MICROKERATOME Bausch & Lomb, Inc., Mar 22, 2004 |