Recall Z-1710-2010 ยท HQF Laser, Ophthalmic
Bausch & Lomb Inc
Bausch & Lomb Millennium Advanced Flow System Phaco Pack, Model CX5310, 6 packs/box, RX, Sterile. 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 surg
| Date | May 28, 2010 (initiated Jan 8, 2010) |
| Status | Terminated |
| Reason | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate |
| 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 prop |
| Quantity | 1,481/6-pack 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033941 | MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK Bausch & Lomb, Inc., Feb 10, 2004 |