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Panel addresses questions about Fusarium investigation
The panel meeting, convened by Bausch & Lomb at the AOA Congress, addressed questions about the outbreak and the product recall.
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LAS VEGAS – A panel of Bausch & Lomb representatives, scientists and optometrists was convened here at the American Optometric Association Congress, to discuss lessons learned to date from investigations of Bausch & Lomb’s ReNu with MoistureLoc solution and its possible link to recent outbreaks of Fusarium keratitis. The solution was recalled from worldwide markets on May 15 after outbreaks of Fusarium infections were reported in Singapore, Hong Kong and the United States.
Bausch & Lomb convened the panel, which was moderated by Joseph T. Barr, OD, MS, FAAO, of Ohio State University. Panelists included Jack Schaeffer, OD, incoming president of the AOA’s Contact Lens and Cornea Section; Chris Snyder, OD, MS, FAAO, a professor of optometry at the University of Alabama at Birmingham; Gary Orsborn, OD, director of marketing for Bausch & Lomb’s North American division; Praveen Tyle, PhD, vice president and chief scientific officer of Bausch & Lomb; and Angela Panzarella, vice president of global vision care for Bausch & Lomb.
The panelists addressed questions that were submitted beforehand from news outlets regarding the causes of the Fusarium outbreak, the company’s decision to recall ReNu with MoistureLoc and the impact of the situation on the future of lens care.
Culture positive Fusarium corneal ulcer in a contact lens wearer showing characteristic hazy white flocculent appearance with fuzzy margins. Images: University of Iowa |
The decision to recall
A question directed to Ms. Panzarella asked why, upon hearing of the first clusters of Fusarium in Hong Kong and Singapore, did Bausch & Lomb not recall the product immediately around the world.
“I think in a recall situation, decisions get critiqued with 20/20 hindsight,” Ms. Panzarella said. “We were dealing with the information we had at the time. There were no unusual trends anyplace else. Based on the information we had, it appeared to be a local situation.”
Another question asked why, once ReNu with MoistureLoc was recalled, it took a long time to get sufficient stocks of other B&L products, such as ReNu MultiPlus, on the shelves as substitutes.
“We had to act quickly, regardless of whether we had substitute stocks,” Ms. Panzarella said. “We were aware that this might disrupt and inconvenience patients, but we were more concerned about safety issues.”
The noncompliance factor
One question directed to Dr. Orsborn asked why, if the outbreaks were related to noncompliance, the Fusarium outbreaks became evident so suddenly. The questioner noted that noncompliance has been an ongoing issue with contact lens wearers.
“We haven’t said that noncompliance is the reason for this,” Dr. Orsborn said. “This is a multifactorial problem dealing with a rare infection. Some aspects of noncompliance in the use of this formulation, related to evaporation or ‘topping off,’ may have contributed. Noncompliance is a factor among many factors.”
The optometrists Drs. Schaeffer and Snyder were asked whether they thought the profession should return to recommending a rubbing regimen for contact lens solutions.
“Absolutely,” Dr. Schaeffer said. “I think we already have, especially with silicone hydrogels.”
Dr. Snyder agreed. “I never really stopped. Rub and rinse is a good option,” he said. “The industry is starting to recognize that. You’ll notice on bottles of solution that the words ‘no rub’ are getting smaller and smaller.”
When asked whether eye care practitioners have become lax in enforcing contact lens care compliance, Dr. Schaeffer was emphatic.
“We haven’t become lax, we are lax,” he said. “This has turned into a wake-up call. We’re now taking control, telling patients that they need to take care of their lenses.”
Ms. Panzarella was asked what will happen if eye care practitioners are sued for having recommended ReNu with MoistureLoc.
“It is our thought that this will be rare,” she said. “If all the doctor did is recommend the solution, they usually don’t have liability. The third-party manufacturer would have liability. But it is an individual-case situation.”
Questions about ReNu MultiPlus
Concerns were also raised about ReNu MultiPlus. One question addressed to Dr. Orsborn asked whether ReNu MultiPlus is compatible with silicone hydrogels.
“We have in vitro and clinical evidence that ReNu MultiPlus is compatible with silicone hydrogels,” he said.
Another questioner asked how the company can suggest that ReNu MultiPlus is compatible with silicone hydrogels when there has been evidence of corneal staining with this solution.
“I put that in context with other signs and symptoms,” Dr. Orsborn said. “I have a happy patient and a normal-looking cornea. If there is some staining, I see it. I grade it. There is no difference in this between ReNu and other solutions.”
The future
Ms. Panzarella was asked how much the Fusarium outbreak and subsequent worldwide withdrawal of ReNu with MoistureLoc from the market has cost Bausch & Lomb.
“The investigation alone cost millions of dollars,” she said. “We’ve had hundreds of scientists focusing on this. Our goal is to recover a lot of it through our other lens care products.”
A question posed to Dr. Schaeffer asked whether the Fusarium issue will result in an overall drop in the use of contact lenses.
“To the contrary,” he said. “Every crisis is opportunity. We are taking better care of patients. Patients have expressed increased interest in their lenses. They have a better appreciation of the fact that contact lenses, if cared for properly, are safe. It has started a dialogue.”
For more information:
- Joseph T. Barr, OD, MS, FAAO, can be reached at Ohio State University, College of Optometry, 320 W 10th Ave., Columbus, OH 43210; 614-292-0437; fax: 614-292-7493.
- Chris Snyder, OD, MS, FAAO, can be reached at 2133 Partridge Berry Road, Birmingham, AL 35244; 205-934-6768; fax: 205-934-6758.
- Jack Schaeffer, OD, can be reached at Schaeffer Eye Center, 1598 Montgomery Highway, Birmingham, AL 35216; 205-968-0141; fax: 205-967-7120.
- Gary Orsborn, OD, director of marketing for Bausch & Lomb’s North American division; Praveen Tyle, PhD, vice president and chief scientific officer of Bausch & Lomb; and Angela Panzarella, vice president of global vision care for Bausch & Lomb, can be reached at 1400 Goodman St., Rochester, NY 14609;585-338-5212; fax: 585-338-0898; Web site: www.bausch.com.