Z-0496-2007

Bausch & Lomb Millennium 20 Ga. High Speed Posterior Vitrectomy Pack, Catalog #CX4920, containing 1/20-gauge...

Name: Z-0496-2007 Bausch & Lomb Millennium 20 Ga. High Speed Posterior Vitrectomy Pack, Catalog #CX4920, containing 1/20-gauge...
Creator: Bausch & Lomb Inc
Published: 2006-12-14
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2006-12-14 / Terminated

FDA source

Bausch & Lomb Inc began a recall of Bausch & Lomb Millennium 20 Ga. High Speed Posterior Vitrectomy Pack, Catalog #CX4920, containing 1/20-gauge high speed vitrectomy cutter as well as other... on 2006-12-14. The reason FDA records is "The cutter tip could break during a procedure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0496-2007
Status: Terminated
Initiated: 2006-12-14
Posted: 2007-05-24
Terminated: 2009-04-07
Recalling firm: Bausch & Lomb Incorporated
Product: Bausch & Lomb Millennium 20 Ga. High Speed Posterior Vitrectomy Pack, Catalog #CX4920, containing 1/20-gauge high speed vitrectomy cutter as well as other accessories. Catalog #USSCX4920A is also included in the recall, which is used by customers for ordering only . There is no labeling associated with this catalog number. This catalog number is used for ordering Cat. #4920 along with Cat. #MVS1011C-20g, Light Pipe (which is not under recall). These two products are packaged separately and are not bundled in any way. They are merely shipped at the same time. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
Product code: HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Reason for recall: The cutter tip could break during a procedure
FDA 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 in commerce: Cat. CX4920 - 4,475 packs; and Cat. CX4920A - 40 packs
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.
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)