ReNu

ReNu is a brand of soft contact lens care products produced by Bausch & Lomb [ [http://www.bausch.com/us/vision/products/softcare/?nav=prodpd. "Lens care products for soft contact lenses."] Bausch & Lomb. Retrieved June 2, 2006.] . The brand recently made headlines regarding a report from the United States Centers for Disease Control and Prevention suggesting an increased incidence of fungal keratitis in people using Bausch & Lomb products.Centers for Disease Control and Prevention (CDC). [http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5514a5.htm "Fusarium keratitis--multiple states, 2006."] "MMWR Morb Mortal Wkly Rep." 2006 Apr 14;55(14):400-1. PMID 16617289.] Bausch & Lomb subsequently suspended, then recalled, shipments of one particular product, ReNu with MoistureLoc [ [http://www.bausch.com/us/vision/about/news/pressrelease.jsp?pressRelease=2006_4_10_reports.html "Bausch & Lomb News".] Bausch & Lomb. Retrieved. June 2, 2006.] .

ReNu with MoistureLoc

On March 3, 2006, New Jersey ophthalmologist Dr. David S. Chu contacted Bausch & Lomb to report that three of his patients had contracted a fungal infection called Fusarium keratitis; all three of these patients were contact lens wearers who used Bausch & Lomb's Renu with MoistureLoc. Subsequently, he also reported his findings to the Centers for Disease Control and Prevention on March 8, 2006. [ [http://www.nytimes.com/2006/05/18/business/18eye.html. "From Asia to America, How Bausch's Crisis Grew"] The New York Times. March 18, 2006. ] [ [http://www.corneajrnl.com/pt/re/cornea/abstract.00003226-200712000-00007.htm;jsessionid=LnLcJkV5hmLbpXcNn4jwnGvLJPR9TV9QZj2QWpTV0P2whGh5lf4X!-927161468!181195628!8091!-1."An Outbreak of Fusarium Keratitis Associated With Contact Lens Use in the Northeastern United States." Cornea, 26:10, December, 2007] ]

On April 10, 2006, the CDC announced that it was investigating 109 patients in the United States suspected to have "Fusarium" keratitis. They reported that they had complete data available for 30 patients in this group, the earliest onset of infection of which was June 15, 2005.

By November 2005, Hong Kong health officials told Bausch & Lomb about a significant increase in hospital admissions due to contact lens related keratitis from June to September 2005 [http://www.monheit.com/ReNu/timeline.asp] .

On April 11, 2006, Bausch & Lomb stopped shipments of its ReNu with MoistureLoc contact lens solution from its Greenville, South Carolina, plant after the U.S. Centers for Disease Control and Prevention found what appeared to be a high correlation between use of the product and cases of suspected fungal keratitis [http://www.bausch.com/us/vision/about/news/pressrelease.jsp?pressRelease=2006_4_10_reports.html] . Similar claims had already been made against the product in Hong Kong and Singapore [http://go.reuters.com/newsArticle.jhtml?type=healthNews&storyID=11717975&src=rss/healthNews] . The news about the U.S. suspension led to a 14.6% drop in the company's stock price -- a drop of $8.41, to $49.03 -- the largest the company experienced in 5 1/2 years [http://today.reuters.com/business/newsarticle.aspx?type=tnBusinessNews&storyID=nN11187878&imageid=top-news-view-2006-03-08-201458-eRPPISA%5B24%5D.jpg&c
] .

On April 13, 2006, Bausch & Lomb announced that it is withdrawing the ReNu with MoistureLoc product world-wide and is recommending that consumers stop using ReNu with MoistureLoc immediately. The FDA supports this decision. The FDA, as well as the American Optometric Association, also advise now that contact lenses be rubbed and rinsed even when a no-rub contact lens solution is used. [ [http://www.allaboutvision.com/contacts/fungal-eye-infections.htm "Fungal Eye Infections and Contact Lens Solutions."] All About Vision. August 24, 2006.]

According to a preliminary report released by the FDA on May 16, 2006, Bausch & Lomb failed to notify the FDA that Singapore's Ministry of Health reported 35 serious cases of "Fusarium" keratitis to Bausch & Lomb in February 2006. [ [http://www.fda.gov/bbs/topics/NEWS/2006/NEW01372.html "FDA Statement on Preliminary Bausch & Lomb Inspection Findings."] May 16, 2006.] [ [http://www.fda.gov/ora/frequent/483s/1032500_baushlomb/baush_lomb_483.pdf Form FDA-483] May 15, 2006.]

The U.S. suspension does not include ReNu products without MoistureLoc.

Only supplies of ReNu with MoistureLoc manufactured in the company's US plant are affected. European supplies are considered to be safe.

On March 7, 2007, Bausch & Lomb issued a voluntary recall on 1.5 Million Bottles of ReNu MultiPlus Solution due to higher than normal amounts of iron in the batch. [ [http://hosted.ap.org/dynamic/stories/B/BAUSCH__LOMB?SITE=AP&SECTION=HOME&TEMPLATE=DEFAULT Associated Press ] ]

References

External links

* [http://www.fda.gov/cdrh/safety/041006-keratitis.html US FDA notification of ReNu withdrawal]
* [http://www.fda.gov/cdrh/medicaldevicesafety/atp/041006-keratitis.html US FDA advice to contact lens wearers]