Bausch and Lomb’s Greenville plant passes FDA inspection

Discontinued contact lens solution manufacturing plant corrects problems

On June 29, 2007, Bausch and Lomb’s Greenville contact lens solution plant passed inspection by the U.S. Food and Drug Administration (FDA). Renu MoistureLoc contact lens solution manufactured at the plant was recalled and discontinued last year after several hundred reports of Fusarium keratitis, a severe infection of the cornea, in Asia and the United States.

Then, in March 2007, the company recalled about 1.5 million bottles of its ReNu MultiPlus solution made at the same Greenville plant because levels of iron in the product were found to cause the cleaner to be less effective.

Source: “Company says contact lens solution plant clears FDA inspection,” WIStv.com, July 17, 2007.

Bausch & Lomb Recalls Second Contact Lens Solution

ReNu MultiPlus Recalled for Trace Iron; No Injuries Reported

Bausch & Lomb, the company forced to recall millions of bottles of contact lens solution last year after hundreds of users contracted keratitis infections and other personal injuries, announced a recall of a second brand of its contact lens solution on March 6, 2007. Twelve lots of ReNu MultiPlus multi-purpose contact lens solution are being recalled. No injuries related to this recall have been reported.

Certain lots of ReNu MultiPlus, a multi-purpose solution marketed for cleaning and storage of soft contact lenses, were recalled by the company after elevated levels of trace iron were found. The lots of recalled ReNu solution were made at the same Greenville, SC Bausch & Lomb plant where Fusarium bacteria was found to have contaminated the company’s ReNu MoistureLoc product.

Over 100 contact lens wearers contracted microbial keratitis during the fungal infection outbreak, which injured people in Singapore as well as the United States. The Centers for Disease Control (CDC) later found that the largest majority of users’ injuries were linked to the ReNu MoistureLoc product.

ReNu MultiPlus is a related product that was not recalled at the time of the outbreak, but was linked to some adverse event reports (Source: CDC Release, April 10, 2006). Bausch & Lomb is now recalling 12 lots of ReNu MultiPlus which were distributed in the U.S., Latin America, Canada, Korea, and Taiwan.

Recalled ReNu MultiPlus solution carries the expiration date “2008-03” on the bottle. Bausch & Lomb is advising contact lens wearers to discard any ReNu MultiPlus solution that may appear discolored.

Source: “Bausch & Lomb recalls second contact lens solution,” Reuters, March 6, 2007.

Two Keratitis Lawsuits Filed Against Bausch

Two couples from Nashville, TN have filed separate personal injury lawsuits against Bausch & Lomb alleging its ReNu with MoistureLoc Multi-Purpose Solution product led to their contraction of the serious bacterial eye fungus Fusarium keratitis. ReNu with MoistureLoc was recalled in May 2006 after the Centers for Disease Control (CDC) confirmed over 180 cases of Fusarium keratitis across the U.S. linked to contact lens solutions.

John Richardson of Clarksville, TN, was diagnosed with Fusarium keratitis, a serious infection of the cornea, in February 2006. Fusarium, a bacterium normally found in soil, water and other organic matter, is rarely known to invade the eye but when it does it can cause permanent damage. Fusarium bacteria actually “invades the cornea,” according to Dr. Jeffrey Sonsino, an optometrist at the Vanderbilt Eye Institute. “One of the reasons it is so serious is because it is very difficult to treat.” Without lengthy treatment, the infection can permanently scar the cornea, leading to vision loss or even blindness.

Richardson was forced to undergo corneal transplant surgery in an attempt to save his eye and “restore some useful vision,” according to his personal injury lawsuit. He suffered permanent vision loss as a result of his exposure to Fusarium keratitis.

Kathy Binkley of Nashville, TN, 44, contracted Fusarium in the form of a “Fusarium corneal ulcer” in November 2005 and underwent a corneal transplant two months later. Since her injury she has suffered decreased, blurred and distorted vision, eye pain, headaches, and sensitivity to light, and may face permanent blindness.

Bausch & Lomb may be facing as many as 700 personal injury lawsuits related to Fusarium keratitis infections and other injuries related to ReNu with MoistureLoc. The CDC called ReNu with MoistureLoc “the potential root cause” of an outbreak of infections worldwide.

“It’s pretty conclusive that this outbreak was due to this product,” Dr. Sonsino said.

Sources: Jared Allen, “Bausch & Lomb eye infections, lawsuits, surface in Nashville,” Nashville City Paper, February 13, 2007; Ben Dobbin, “Bausch & Lomb sees 2006 revenue falling below previous guidance on slow recovery,” January 31, 2007, accessed February 13, 2007.

FDA warns Bausch & Lomb in ReNu solution investigation

No direct link found between S.C. facility and cause of Fusarium infections, but other problems found

On November 6, 2006, the Food and Drug Administration (FDA) released a warning letter it sent to Bausch & Lomb Inc. after it found violations in the company’s Greenville, SC plant. The FDA inspected the plant following reports that some users of Bausch & Lomb’s ReNu with MoistureLoc contact-lens solution contracted a rare eye infection, Fusarium keratitis.

Bausch & Lomb announced a world-wide recall of the cleaning solution in May 2006 after announcing the product’s formulation, when combined with certain patient use patterns, may lead to an increase in risk of Fusarium keratitis, a fungal eye infection that can lead to blindness. The company is now facing product liability lawsuits related to the case.

The FDA’s letter followed an inspection of the company’s plant, and said that while it did not find any conditions that may have contributed to or caused the infection, it did find “numerous other manufacturing problems” that are systemic and related to all products manufactured in the facility.

Some of the problems identified include:

• Failure to establish and maintain procedures that ensure a device’s design include a way to address incomplete, unclear or conflicting requirements
• Failure to establish and maintain procedures to prevent the contamination of equipment or products that may have an unfavorable effect on product quality
• Failure to establish and maintain procedures to efficiently control environmental conditions, such as temperature conditions
• Failure to ensure that all equipment used in the plant to manufacture products meets specifications
• Failure to document maintenance activities
• Failure to review, evaluate and investigate complaints involving the possible failure of a device labeling or packaging, including complaints relating to the ReNu with MoistureLoc Multi-Purpose solution that is believed to be linked to the eye infection

There have been 164 confirmed cases of Fusarium infections in 33 states and one US territory. 60 percent of the cases involved a patient reportedly using ReNu with MoistureLoc.

The FDA gave Bausch & Lomb 15 days to submit a plan for correcting the violations. Also in the warning letter, the FDA said it found no evidence of clinical problems relating to any other Bausch & Lomb products.

Sources: US Food and Drug Administration Warning Letter, October 31, 2006; Patricia Kowsmann, “FDA warns Bausch & Lomb on lens-solution infections,” Wall Street Journal, November 7, 2006; Ben Rand, “Bausch & Lomb gets warning from FDA on plant,” Rochester Democrat and Chronicle, November 7, 2006.

JAMA report concludes Bausch & Lomb product contributed to outbreak of fungal eye infections

Bausch & Lomb’s ReNu with MoistureLoc lens cleaning solution was the only contact lens solution that was a contributing factor in the outbreak of fungal eye infections in the U.S. since June of 2005, according to the team of federal disease control experts and leading eye doctors analyzing adverse event reports on behalf of the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention. Their report, published in today’s edition of the Journal of the American Medical Association (JAMA), challenges Bausch & Lomb’s assertion that it was customers’ failure to properly clean and store their contact lenses that contributed to their infections rather than a defect in the product itself.

It is still not clear exactly how ReNu with MoistureLoc contributes to Fusarium keratitis, the rare fungal infection that was confirmed in the 164 cases analyzed by researchers. Previously, Fusarium keratitis was only rarely seen among some rural agricultural workers who might have received a scratch in their eye from a plant that contained the fungus. Previous research reports found that the majority of users reported using ReNu with MoistureLoc to clean and care for their contact lenses prior to contracting Fusarium keratitis. Just over one-third of the total survey of 164 patients suffering from Fusarium keratitis in the U.S. required corneal transplants to recover from the damage to their eyes.

The reports authors concluded that there was still not enough evidence to identify the exact problem with Bausch & Lomb’s product, and that more research is needed. Dr. Todd P. Margolis of the Proctor Foundation for Ophthalmology Research at the University of California in San Francisco co-authored the commentary that accompanied today’s JAMA report. Dr. Margolis stated that cases of Fusarium keratitis may have started to rise before ReNu with MoistureLoc was first marketed. “There are many cases out there that haven’t been fully investigated,” Dr. Margolis said. While adverse event reports concerning Fusarium keratitis have slowed down considerably, healthcare experts continue to hear reports of infections that appear to be related to ReNu with MoistureLoc.

Bausch & Lomb recalled ReNu with MoistureLoc in the U.S. on May 15, 2006, after removing the product from some Asian markets as early as February. The company eventually concluded that the product formulation might allow Fusarium to colonize a lens case or bottle cap, especially if a consumer tops off his existing solution in a contact lens case instead of completely replacing it. Researchers found that while there was some evidence that topping off solution may raise a person’s risk of infection, there appeared to be no difference between the practices of the people who were infected and those contact lens wearers who remained healthy.

“Practicing good contact lens hygiene is a prudent and common-sense measure for all contact lens wearers, irrespective of contact lens solution used,” Dr. Douglas C. Chang wrote in an e-mail interview according to the New York Times. Dr. Chang is a CDC fungal disease specialist and lead author of the report. “However, the most important message for contact lens wearers is to stop using MoistureLoc.”

Sources: Barnaby J. Feder, “Lens Solution Caused Eye Infections, Report Says,” New York Times, August 22, 2006, accessed August 23, 2006; Douglas C. Chang, MD, et. al, “Multistate Outbreak of Fusarium Keratitis Associated With Use of a Contact Lens Solution,” Journal of the American Medical Association 296:8 (August 23-30, 2006).