Contact Lenses Forum - Lens 101
contact lenses

Go Back   Contact Lenses Forum - Lens 101 > News Archives > News Archives - 2006 > May 2006
Register FAQ Members List Calendar Search Today's Posts Mark Forums Read

May 2006 Contact Lens related news articles for May 2006

Join Lens 101Welcome to the Contact Lenses Forum - Lens 101 forums.

You are currently viewing our boards as a guest which gives you limited access to view most discussions and access our other features. By joining our free community you will have access to post topics, communicate privately with other members (PM), respond to polls, upload content and access many other special features. Registration is fast, simple and absolutely free so please, join our community today!

F.D.A. Report Faults Maker of Contact Lens Solution

This is a discussion on F.D.A. Report Faults Maker of Contact Lens Solution within the May 2006 forums; Bausch & Lomb failed to notify United States regulators within 30 days about 35 serious ...

LinkBack Thread Tools Display Modes
Site Sponsor
  #1 (permalink)  
Old 05-17-2006, 10:20 AM
Join Date: Oct 2004
Posts: 5,098
Default F.D.A. Report Faults Maker of Contact Lens Solution

Bausch & Lomb failed to notify United States regulators within 30 days about 35 serious bacterial infections reported in Singapore in users of its ReNu With MoistureLoc contact lens solution, the Food and Drug Administration said in a report released on Tuesday.

The finding was among 20 observations of potential violations the F.D.A. listed after inspecting Bausch & Lomb plants in Greenville, S.C.

The F.D.A. report came a day after the company permanently withdrew ReNu With MoistureLoc from the market expanding an earlier recall because the product may increase the risk of a fungal eye infection that can result in blindness.

The agency also said that Bausch & Lomb did not notify it in writing that it had withdrawn the solution from sale in Singapore and Hong Kong in February.

According to the report posted on the F.D.A.'s Web site, Bausch & Lomb failed, as well, to follow proper procedures to prevent contamination of equipment at the plant.

A spokeswoman for the company, Meg Graham, said in a statement that it was working with the F.D.A. to address its observations.

Bausch's chief executive, Ronald L. Zarrella, said Monday that the costs associated with the recall would be $50 million to $70 million. The company is also facing about $100 million in lost ReNu sales and will presumably have to spend on marketing to recover market share.

Executives initially thought that the infection might have been linked to contamination at its plant in Greenville.

But the F.D.A., which found manufacturing problems not connected with the outbreak, said the cases appeared to be related to the design and use of the ReNu With MoistureLoc formula.

Last month, Bausch & Lomb withdrew the product in the United States after it was linked to a number of the fungal infections. The recall now extends to regions where the company has seen no unusual trends in these infections, including Europe, the Middle East, Africa and China.

The F.D.A. said data so far did not indicate problems with Bausch & Lomb's ReNu MultiPlus or ReNu Multi-Purpose brands. MultiPlus, though, has been linked with the fungal infection in reports by the Centers for Disease Control and Prevention. In trading Tuesday, Bausch & Lomb shares fell $1.37, to $48.71.
Any news articles or press releases can be submitted as word or text documents to

Archives Administrator

Bookmark This Site

Currently Active Users Viewing This Thread: 1 (0 members and 1 guests)
Thread Tools
Display Modes

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off
Trackbacks are On
Pingbacks are On
Refbacks are On

All times are GMT -5. The time now is 05:39 AM.

Contact Lenses

/ Contact Lens Forums
Daily Disposable Contact Lenses 2
1-2 Week Disposable Contact Lenses
Monthly Disposable Contact Lenses
Color Contact Lenses 2 3 4 5 6 7
Gas Permeable Contact Lenses 2 3
Toric Contact Lenses 2 3
Bifocal Contact Lenses 2
Vial Contact Lenses
Other Contact Lenses 2 3, & Contact Lens Care 2 3 4 5 6 7 8 9 10 11

Powered by vBulletin® Version 3.8.4
Copyright ©2000 - 2017, Jelsoft Enterprises Ltd.
SEO by vBSEO 3.2.0 RC7 ©2008, Crawlability, Inc.
Copyright 2001 - 2010, Inc. All rights reserved.

Any materials provided on this web site are for informational purposes only. Have your eyes examined regularly and always follow your eye care professional's instructions for the proper use and care of your contact lenses. IF YOU ARE HAVING ANY UNEXPLAINED EYE DISCOMFORT, WATERING, VISION CHANGE OR REDNESS, REMOVE YOUR LENSES IMMEDIATELY AND CONSULT YOUR EYE CARE PROFESSIONAL BEFORE WEARING YOUR CONTACT LENSES AGAIN.

Site operated by, Inc.