FDA Medical Device Recalls (openFDA)
Bausch & Lomb Inc: Bausch & Lomb Lightning High Speed Vitrectomy Cutter, Catalog #CX4804, 1/20-gauge high speed vitrectomy cutter per package. The firm name on the label is Bausch & Lomb incorporated, Rochester, NY.
- Recall number
- Z-0495-2007
- Recalling firm
- Bausch & Lomb Inc
- Product
- Bausch & Lomb Lightning High Speed Vitrectomy Cutter, Catalog #CX4804, 1/20-gauge high speed vitrectomy cutter per package. The firm name on the label is Bausch & Lomb incorporated, Rochester, NY.
- Status
- Terminated
- Initiated
- 2006-12-14
- Posted
- 2007-05-24
- Terminated
- 2009-04-07
- Reason
- The cutter tip could break during a procedure
- Root cause
- Other
- Action
- 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.
- Quantity
- 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 The Netherlands.
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K980488"]
- PMA numbers
- not on file
- Product code
- HQE
- Firm FEI
- 1317628
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28