In the wake of voluntary global recall issued late last week related to one of its contact lens solutions, American Medical Optics (AMO; Santa Ana, California) said in a conference call yesterday morning that it stands by the quality of the product. Instead, it blamed improper handling of contact lenses for the eye infections that forced the product to be pulled from the shelves.

The company said it recalled its Complete Moisture Plus Multi-Purpose Solution as a precaution because of reports linking it to a rare, and serious, eye infection, acanthamoeba keratitis (AK), caused by a parasite. The link between the solution and the infection was identified as a result of an investigation by the Centers for Disease Control and Prevention (CDC; Atlanta).

The CDC has estimated that AK infections occur in around 2 out of every 1 million contact lens users in the U.S. annually. But it said that it performed a multi-state investigation of recent AK cases and determined that the risk of developing AK was at least seven times greater for those consumers who used Complete MoisturePlus solution vs. those who did not.

"What we're trying to handle right now … is what the CDC hit us with," said James Mazzo, president/CEO of AMO, during the conference call.

The eye infection, caused by a waterborne organism, can lead to permanent vision loss or blindness, the CDC said.

Acanthamoeba is a microorganism commonly found in water, soil, sewage systems, cooling towers, and heating/ventilation/air conditioning systems. AK is usually found among individuals who improperly store/handle/disinfect their lenses (e.g., use tap water or homemade solutions for cleaning), swim/use hot tubs/shower while wearing lenses, come in contact with contaminated water, have minor damage to their corneas, or have previous corneal trauma.

This latest outbreak is reminiscent of the one that plagued Bausch & Lomb's (Rochester, New York) ReNu with Moisture Loc contact lens cleaning solution last year and caused the company to recall that product last year (Medical Device Daily, April 17, 2006).

That outbreak, in which 164 confirmed cases were reported, was caused by a different microbe, fusarium keratitis, a fungus.

In an ironic twist, AMO expressed interest last week in acquiring B&L by topping private equity firm Warburg Pincus' recent $3.67 billion bid for the company (MDD, May 25, 2007). It remains to be seen what, if any, impact this recall has on its purchasing fervor.

CDC officials Friday warned people to throw away the product, used for cleaning and storing soft contact lenses, after an investigation linked it to the rare eye infection.

"It's not a manufacturing problem or a contamination issue," said Mazzo, who added that the infection affects people who improperly handle contact lenses, such as disinfecting them with water or wearing them while swimming or showering.

"AK is something the vast majority of contact lens users typically avoid by following their eye practitioner's advice," Mazzo said. "It's important to understand that the CDC does not believe that AK is something that is caused by lens care solutions," Mazzo emphasized. "It's not a manufacturing problem or a contamination issue. All of our products, including Moisture Plus, have always met and continue to meet all FDA requirements."

CFO Randy Meier said that the Moisture Plus products' $105.7 million in 2006 sales represent about 10% of the company's total consolidated sales.

"We're still working through the details to determine how much of that revenue will be impacted by the recall," Meier said. "It is impossible to assess what path we'll take or what the impact will be to our future earnings."

Meier said the company will update investors early next week.

"While this recall is clearly a setback for our eye care business, none of our other products will be affected," Meier said.

The CDC and the FDA are investigating 138 confirmed cases since January 2005.

Mazzo said the CDC interviewed 46 people who were confirmed to have the infection dating back to 2005, 39 of whom were soft contact lens users. Of those users, 21 reported using the AMO solution.

CDC officials said people should discard the solution, throw out their current contact lenses and toss away the lens storage case. All of them may harbor the infecting amoeba, the agency said.

"The bottom line is that we take our commitment to safety very seriously, and we therefore decided out of abundance of caution that we would voluntarily recall the product," said Mazzo.

Bear Stearns med-tech analyst Rick Wise wrote in a research report that based on management's comments and the nature of AK, he believes the core issue with Complete Moisture Plus is the formulation/reaction of certain molecules in conjunction with foreign substances.

He also noted that though unrelated to B&L's Moisture Loc recall, "we believe that sub-optimal contact lens compliance has played a vital role in recent multi purpose solution recalls and would not rule out a market shift to older generation rub indicated formulas or a saline/enzyme combination."

Wise also said that he believes the recall could boost AMO's interest in B&L (B&L continues to sell ReNu and ReNu MultiPlus) despite the financial challenges. "However, given that contact lens solutions have historically been one of the best free cash flow generating products in the ophthalmology market, the lack of a new technology multi purpose solution could potentially make financing a B&L deal more complicated now for AMO."

Regardless of Mazzo's assertions about the safety of the product, Daniel Schultz, MD, director of the FDA's Center for Devices and Radiological Health said the company did the right thing by initiating the recall.

"We believe the company acted responsibly in taking this voluntary action and support their decision to be proactive in the interest of public health," said Schultz. "FDA and CDC are working closely with the company to collect additional information and we will continue to alert consumers and advise them as more information becomes available."

It too emphasized the need to perform the correct lens cleaning procedures.