Bausch & Lomb Millennium Basic Venturi Phaco Pack, Models DP4305 and DP4305E, 12 packs/box, RX, Sterile. The firm name o

FDA device recall Z-1708-2010 · posted 2010-05-28 · Terminated

Recall details

Recalling firm

Bausch & Lomb Inc

Reason for recall

Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate

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.

Root cause

Component design/selection

Status

Terminated

Product code

HQC

Quantity affected

7,256/12-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.

Date initiated

2010-01-08

Date posted

2010-05-28

Date terminated

2012-04-02

Location

Rochester, NY

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