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U.S. Department of Health and Human Services

Class 2 Device Recall Bausch & Lomb Stellaris 1.8mm Micro Incision AFS Phaco Pack with MICS Needle

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  Class 2 Device Recall Bausch & Lomb Stellaris 1.8mm Micro Incision AFS Phaco Pack with MICS Needle see related information
Date Initiated by Firm January 08, 2010
Date Posted May 28, 2010
Recall Status1 Terminated 3 on April 02, 2012
Recall Number Z-1721-2010
Recall Event ID 54200
510(K)Number K063331  
Product Classification unit, phacofragmentation - Product Code HQE
Product Bausch & Lomb Stellaris 1.8mm Micro Incision AFS Phaco Pack with MICS Needle, Model BL5123, 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.
Code Information U1644
Recalling Firm/
Manufacturer
Bausch & Lomb Inc
1400 North Goodman Street
Rochester NY 14609-3547
For Additional Information Contact Chris Willis
949-297-3511
Manufacturer Reason
for Recall
Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
FDA Determined
Cause 2
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 635/6-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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HQE and Original Applicant = BAUSCH & LOMB, INC.
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