Recall Z-1022-2007
Bausch & Lomb Inc · initiated June 8, 2007
Product
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 Microkeratome, which is not under recall.
Codes / lots: All lots
Reason for recall
Reports have been received of stromal incursions after use of the product.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-1022-2007
- Initiated
- June 8, 2007
- Posted by FDA
- August 2, 2007
- Terminated
- April 28, 2009
- Product code
- HNO – Keratome, Ac-Powered
- 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.
- Recalling firm
- Bausch & Lomb Inc, Rochester, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1021-2007 | Bausch & Lomb Zyoptix XP Epi Separator, packaged 1 per sterile pouch, 10 per carton…Reports have been received of stromal incursions after use of the product. | 06/08/2007Terminated |