Z-1727-2010

Bausch & Lomb MicroFlow Plus 30 Phaco Needle, Model DP8330S, 6 pouches/box. The firm name on the label is...

Name: Z-1727-2010 Bausch & Lomb MicroFlow Plus 30 Phaco Needle, Model DP8330S, 6 pouches/box. The firm name on the label is...
Creator: Bausch & Lomb Inc
Published: 2010-01-08
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2010-01-08 / Terminated / root cause: design

FDA source

Bausch & Lomb Inc began a recall of Bausch & Lomb MicroFlow Plus 30 Phaco Needle, Model DP8330S, 6 pouches/box. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY. The... on 2010-01-08. The reason FDA records is "Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1727-2010
Status: Terminated
Initiated: 2010-01-08
Posted: 2010-05-28
Terminated: 2012-04-02
Recalling firm: Bausch & Lomb Incorporated
Product: Bausch & Lomb MicroFlow Plus 30 Phaco Needle, Model DP8330S, 6 pouches/box. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery.
Product code: HQC Unit, Phacofragmentation
Reason for recall: Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Root cause tag: design
FDA root cause: Component design/selection
Action: The recalling firm, Bausch & Lomb, issued an "URGENT: PHACO NEEDLE WRENCH CORRECTION" letter dated January 7, 2010, via first class mail to all customers. The letter describes the product, problem and actions to be taken by the customers. The letter also provides instructions and pictorial representations demonstrating proper seating of the needle to the wrench as well as a description of the appropriate force to tighten the needle to the handpiece. The customers were instructed to please read and follow the attached instructions entitled (Potential for Particulate Matter in the eye and proper assembly and use of needle wrench) and fill-out and return/fax at 949-716-8362, the Bausch & Lomb Phacoemulsification Needle Wrench Particulate correction form. If you have any questions or concerns please contact, Chris Willis or Stephen Haight at 1-800-387-3284.
Quantity in commerce: 2,282/6-pouch boxes
Distribution: Worldwide distribution: USA and Germany, France, Italy, Norway, Sweden, Finland, The Netherlands, Switzerland, U.K., Austria, Luxembourg, Ireland, Hong Kong, New Zealand, India, Australia, and Japan.
Product codes and lots: U2578

Product code HQC

K954340Class IIStorz Microflow Phacoemulsification NeedleStorz / cleared 1995-12-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)