Eye Infections From Solution Continuing to Harm Users

More than a fourth of the contact lens users who suffered serious eye infections linked to Advanced Medical Optics' recalled Complete MoisturePlus lens cleaner have required corneal transplants, according to an update on the outbreak released yesterday by federal health care authorities.
"This is just as serious as the fusarium outbreak," said Lola Russell, a spokeswoman for the Centers for Disease Control and Prevention, referring to an outbreak of fungal eye infections last year that was linked to Bausch & Lomb's ReNu with MoistureLoc lens cleaners.
The recall by Advanced Medical stemmed from MoisturePlus' s apparent inability, for reasons that are not yet clear, to adequately protect some soft lens users from a different infectious microbe called acanthamoeba. The update, like previous reports, confirmed that the outbreak had affected a tiny fraction of the nation's estimated 30 million soft lens users. The C.D.C. has investigated 102 patients who had confirmed acanthamoeba infections as of June 25. But the newer data is in line with the results that led to the recall - a much higher proportion of those who suffered infections used MoisturePlus than would be expected from the product's relatively small market share, according to Ms. Russell.
A recent C.D.C. study found more than half of contact lens users were unaware that Advanced Medical had started a worldwide recall of MoisturePlus cleaners in May. Less than 27 percent of those who knew of the recall could correctly identify the product involved.
The survey, which covered 151 healthy contact lens users, also found that of the 21 who were using MoisturePlus at the time of the recall, 15 had not heard about the recall and continued to use the product. At least four of those users developed infections, according to a report posted on the C.D.C. Web site Tuesday. Both the C.D.C. and the Food and Drug Administration expressed growing concern about the possibility that lack of attention among consumers and doctors to the recall was leading to unnecessary risks.
"We asked the company in a meeting last week to step up its efforts to publicize the recall," said Kristine Mejia, a spokeswoman for the F.D.A. On Wednesday, the agency issued a notice to consumers on its Web site saying the recall is a Class I event, its most serious level of recall. The agency said Advanced Medical, based in Santa Ana, Calif., had initially focused its recall efforts on communications with eye care professionals and retailers. The F.D.A. said Advanced Medical reported that it had distributed more than 57 million bottles worldwide, including nearly 28 million in the United States, in the two years before the recall began. How many remain in circulation is not clear.
Advanced Medical said it believed its publicity efforts had been "appropriate to ensure the effectiveness of the recall." Advanced Medical's call center in the United States has received nearly 100,000 calls, including more than 55,000 requests from consumers for product return and reimbursement kits, according to Steve Chesterman, a spokesman. Mr. Chesterman said in an e-mail message that the C.D.C. findings were based on "a limited number of interviews." He said the company was working with the C.D.C. and the F.D.A. to "further evaluate" the results of its communications efforts.
[NYT]