Z-0765-2007

Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy Cutter, Catalog No. CX5825...

Name: Z-0765-2007 Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy Cutter, Catalog No. CX5825...
Creator: Bausch & Lomb Inc
Published: 2007-02-09
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2007-02-09 / Terminated

FDA source

Bausch & Lomb Inc began a recall of Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy Cutter, Catalog No. CX5825, packaged individually in a Tyvek pouch, 6/box, RX... on 2007-02-09. The reason FDA records is "The cutter probe tip breaks during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0765-2007
Status: Terminated
Initiated: 2007-02-09
Posted: 2007-04-21
Terminated: 2009-04-07
Recalling firm: Bausch & Lomb Incorporated
Product: Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy Cutter, Catalog No. CX5825, packaged individually in a Tyvek pouch, 6/box, RX. The firm names on the label are Bausch & Lomb Incorporated, Rochester, NY, and Bausch & Lomb Incorporated, Kingston-upon-Thames, UK.
Product code: HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Reason for recall: The cutter probe tip breaks during use.
FDA 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 in commerce: 32,190 units of Catalog No: CX 5825
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
Product codes and lots: All lots

Product code HQE

K980488Class IIStorz Millennium Microsurgicl System High Speed Vitrectomy SystemStorz Instrument Co. / cleared 1998-03-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)