Bausch & Lomb Zyoptix XP Epi Separator, packaged 1 per sterile pouch, 10 per carton, Reorder No. 507-0068, RX, for singl
FDA device recall Z-1021-2007 · posted 2007-08-02 · Terminated
Recall details
- Recalling firm
- Bausch & Lomb Inc
- Reason for recall
- Reports have been received of stromal incursions after use of the product.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- HNO
- Quantity affected
- 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.
- Date initiated
- 2007-06-08
- Date posted
- 2007-08-02
- Date terminated
- 2009-04-28
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZYOPTIX XP EPI SEPARATOR SYSTEM (K062465) | Bausch & Lomb, Inc. | 2006-09-06 |
| ZYOPTIX XP MICROKERATOME (K040204) | Bausch & Lomb, Inc. | 2004-03-22 |