Bausch & Lomb Lightning High Speed Vitrectomy Cutter, Catalog #CX4804, 1/20-gauge high speed vitrectomy cutter per packa
FDA device recall Z-0495-2007 · posted 2007-05-24 · Terminated
Recall details
- Recalling firm
- Bausch & Lomb Inc
- Reason for recall
- The cutter tip could break during a procedure
- Action taken
- Recall letters were issued via e-mail to surgeons on 12/14/06 and via overnight mail on 12/14/06 to surgeons and operating room supervisors requesting immediate segregation and return of the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- HQE
- Quantity affected
- Cat. CX4804 - 3,485 Cutter Tips
- Distribution
- Worldwide distribution ---- including USA and countries of Canada, China, Japan, Australia, Hong Kong, India, Malaysia, New Zealand, Singapore, Korea, Taiwan, Thailand, Argentina, Brazil, Mexico, and
- Date initiated
- 2006-12-14
- Date posted
- 2007-05-24
- Date terminated
- 2009-04-07
- 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 |
|---|---|---|
| STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM (K980488) | Storz Instrument Co. | 1998-03-23 |