Bausch & Lomb Stellaris 1.8mm StableChamber Phaco Pack with MICS Angled Needle, Model BL5113A, 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 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.
This recall has been terminated (originally issued May 28, 2010).
- Company
- Bausch & Lomb Inc
- Recall Initiated
- January 8, 2010
- Posted
- May 28, 2010
- Terminated
- April 2, 2012
- Recall Number
- Z-1718-2010
- Quantity
- 345/6-pack boxes
- Firm Location
- Rochester, NY
- Official Source
- View on FDA website ↗
Reason for Recall
Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
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.
Lot / Code Info
U2336
Root Cause
Component design/selection
Action Taken
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.