FDA Medical Device Recalls (openFDA)
Bausch & Lomb Inc: Bausch & Lomb Millennium TSV 25 Ga. High Speed Posterior Vitrectomy Pack, Catalog No: CX4925, containing 1/25-ga. cutter along with accessories, RX. The firm names on the label are Bausch & Lomb Incorporated, Rochester, NY, and Bausch & Lomb Incorporated, Kingston-upon-Thames, UK.
- Recall number
- Z-0766-2007
- Recalling firm
- Bausch & Lomb Inc
- Product
- Bausch & Lomb Millennium TSV 25 Ga. High Speed Posterior Vitrectomy Pack, Catalog No: CX4925, containing 1/25-ga. cutter along with accessories, RX. The firm names on the label are Bausch & Lomb Incorporated, Rochester, NY, and Bausch & Lomb Incorporated, Kingston-upon-Thames, UK.
- Status
- Terminated
- Initiated
- 2007-02-09
- Posted
- 2007-04-21
- Terminated
- 2009-04-07
- Reason
- The cutter probe tip breaks during use.
- Root cause
- Other
- Action
- On 2/12/07, express mail letters were addressed to operating room supervisors to notify them of the recall. Additional E-mail notifications were issued on 2/14/07 to doctors and letters were addressed to them on 2/20/07 to make them aware of the recall, although they do not directly receive the product. The communications instructed them to not use the affected product and to return it, along with the business reply card.
- Quantity
- 13,685 units of Catalog No: CX4925
- Distribution
- Class II Recall - Worldwide Distribution --- USA including states of MO, NC, FL, CA, and TX and countries of Canada, China, Japan, Australia, Hong Kong, India, 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