Stick to your usual prescribing habits is the advice given by contact lens
experts in the wake of the recent recall of peroxide lens care system Peroxiclear from Bausch + Lomb.
The company voluntarily withdrew Peroxiclear from the market under a proposed Class II recall (See “FDA product recalls” below) and requests retailers, wholesalers, and eyecare practitioners (ECPs) to return the product.
Chris Marschall, vice president of eye care marketing at Bausch + Lomb, says the company will take back at its expense Peroxiclear samples ECPs may have in inventory; however, it is not requesting product back from patients.
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“We are recommending that ECPs counsel their patients in the way that they deem most appropriate,” he says. “They know what their patients need. We recommend that if their patients require peroxide disinfection, they move patients into another peroxide system on the market.”
Marschall says the company plans to bring Peroxiclear back to the market as soon as possible; however, no date has been set and the return will likely not happen in the next six months.
Says Optometry Times
Editorial Advisory Board member Crystal Brimer, OD, FAAO: “We have all had patients come into the office after misusing a peroxide solution at full concentration and, in my experience, their discomfort resolves and there is no permanent damage. This is an unfortunate event for Bausch + Lomb, and perhaps a sign that there always needed to be more longevity to its neutralization disc, but it does not mean Peroxiclear is a bad product.”
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Advice from the experts
ECPs have several choices for their Peroxiclear-using patients, from other peroxide solutions to multipurpose solutions or even refitting patients into daily disposable contact lenses to reduce the need for lens care.
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If you normally prescribe a peroxide disinfection system for your contact lens patients, continue to do so, advises Brittany Mitchell, OD, Optometry Times
Editorial Advisory Board member.
“I recommend that doctors continue practicing in the same exact way,” she says. “I have always recommended a hydrogen peroxide solution to my patients; therefore, I have changed my patients to a different hydrogen peroxide solution because Peroxiclear is currently not available. It’s up to each doctor and how they practice whether to change patients to a different brand of peroxide or to a multipurpose solution.”
Editorial Advisory Board member Mile Brujic, OD, FAAO, says ECPS are fortunate to have a number of options for contact lens care.
“Biotrue (Bausch + Lomb) seems to be appropriate if a multipurpose solution is indicated,” he says. “If a peroxide system is most appropriate for patients, Clear Care (Alcon) is a viable option. Patients simply need to be educated that it requires a six-hour minimum disinfection cycle as opposed to the four-hour cycle with Peroxiclear.”
Editorial Advisory Board member David Geffen, OD, FAAO, reminds his colleagues that fitting patients into daily disposable contact lenses eliminates concerns about lens care.
“I am a great fan of daily disposables,” he says. “Our practice is about 75 percent daily disposables in the soft lens part of the practice. They eliminate many of these type of concerns, and for the majority of patients I believe they are a healthier option.”
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Reasoning for the recall
Bausch + Lomb pulled Peroxiclear from the shelves due to residual peroxide remaining in the lens case after peroxide neutralization. The amount of remaining peroxide was out of product specification.
“On a frequent basis, we’re testing our product,” Marschall says. “The problem was identified when we were simulating normal product use using the lens case over 35 uses. That’s the length of the lens case life. We found occasional occurrences where that residual peroxide was higher.
“It was enough for us to take this voluntary action so we’re not putting something in the marketplace that is not meeting our standards.”
The company also received a limited number of patient complaints related to stinging and burning from the residual peroxide.
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Bausch + Lomb is working to identify what needs to be fixed with the process of peroxide solution and neutralizing disc working together.
“We recognize that patients are going to go back to Clear Care or private label peroxide systems,” Marschall says. “We want to get back into the market with Peroxiclear, which has significant advantages. We hope to get those patients back when we relaunch the product.”
ECPs may remember another Bausch + Lomb lens care recall 10 years ago: ReNu with MoistureLoc solution in April 2006.
MoistureLoc was pulled from the shelves due to an outbreak of Fusarium
keratitis which ultimately required corneal transplants for some patients.
“It is a completely different situation,” says Marschall. “We’ve taken proactive action here. Out of an abundance of caution, we are doing this voluntary recall. It is not a consumer-level recall. We are not requesting product back from patients. We’ve heard from doctors that they appreciate that we are being proactive and we are communicating with them about what we’re doing.”
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FDA product recalls
According to the FDA website
, a product may be recalled or withdrawn from the market in a variety of ways. The product may be voluntarily removed from the market, or the withdrawal may occur under FDA request or order.
The categories of product withdrawal or recall are:
• Class I recall: Use of or exposure to a violative product will likely cause serious adverse health consequences or death.
• Class II recall: Use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
• Class III recall: Use of or exposure to a violative product is not likely to cause adverse health consequences.
• Market withdrawal occurs when a product has a minor violation that would not be subject to FDA legal action. The manufacturer removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.
• Medical device safety alert is issued for situations in which a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.
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