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  1. #1
    tired donnamb's Avatar
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    Soft Contact Lens Wearers: Please Read About this Recall!

    I just spent some time throwing away my contacts, all my extra cases, and calling the recall line to order a return package for my saline solution. There is an outbreak of acanthamoeba keratitis that in its extreme can cause blindness and/or a need for a corneal transplant. There's only one solution on the market affected - AMO Complete MoisturePlus. Unfortunately, it is the one I use. In case you're not sure what you use, here's what the packaging looks like:



    Here is a letter from the company with all the relevant return/refund information: AMOrecallletter.pdf

    Here are the NYT articles on the recall.
    May 27, 2007
    Lens Solution Is Pulled Over Link to Infection

    By LAWRENCE K. ALTMAN
    A contact lens solution manufacturer voluntarily withdrew one of its products yesterday after federal health officials said an investigation had linked it to a rare but potentially blinding eye infection.

    Customers were advised to immediately stop using the solution, AMO Complete Moisture Plus Multi-Purpose Solution. The solution, used to clean and store soft contact lenses, is made by Advanced Medical Optics of Santa Ana, Calif.

    Soft contact lens wearers who have the AMO solution were advised to discard all partially used or unopened bottles and switch to alternative products. They should also throw out their current contact lenses and the lens storage case because they may harbor an infection-causing amoeba, officials of the federal Centers for Disease Control and Prevention in Atlanta said.

    The agency also advised people who have used the product to call an eye doctor if they have experienced eye pain or redness, blurred vision, sensitivity to light, the feeling of something in the eye or excessive tearing. The symptoms, which resemble those of other eye problems, can last weeks to months and vary among patients.

    Advanced Medical Optics said it withdrew the product as a precaution after the epidemiologists at the disease control centers said they had identified 138 laboratory confirmed cases of the infection, Acanthamoeba keratitis, that have occurred throughout the country since January 2005. Keratitis is inflammation of the cornea.

    The authorities said that the link was “preliminary” and that it had not determined precisely how the patients became infected. But investigators found that the risk of developing the infection was at least seven times greater for those people who used the AMO product than for those who did not.

    The company said, “There is no evidence to suggest that the voluntary recall is related to a product contamination issue and this does not impact any of AMO’s other contact lens care products.”

    Acanthamoeba infection usually develops slowly and can be difficult to diagnose and treat. Doctors often attribute Acanthamoeba infections at first to a virus, herpes simplex, that is treatable. But the drugs for herpes do not help Acanthamoeba patients. Doctors advise treating the infection as early as possible.

    The amoeba is ubiquitous and often found in tap and recreational water, soil, sewage, cooling towers and heating and ventilation systems. It is not spread person-to-person.

    So far, epidemiologists have interviewed 46 of the 138 patients with confirmed cases of the illness. Of the 46, 39 (85 percent) wore soft contact lenses, 3 (7 percent) wore rigid lenses and 4 (9 percent) reported no contact lens use.

    Acanthamoeba keratitis usually affects healthy people who wear contact lenses. About 85 percent of the cases reported in this country have occurred in contact lens users, including wearers who say they follow recommended contact lens-care practices, health officials said.

    Though the number of cases is small compared with the estimated 30 million soft contact lens users in this country, the infection can lead to a corneal transplant or removal of an eye.
    May 28, 2007
    Outbreak of Eye Infections Puzzles Officials

    By LAWRENCE K. ALTMAN
    Health officials and eye doctors are puzzled by an outbreak of a rare but potentially blinding eye infection that led the manufacturer of a contact lens cleaning solution to withdraw one of its products this weekend.

    The outbreak resembles one last year that was linked to a different manufacturer’s lens solution and a different microbe. In both instances, the cornea, the eye’s transparent outer covering, is at risk. But why two different microbes caused the outbreaks is not known.

    “It is beyond comprehension,” said Dr. Dan B. Jones, the chairman of ophthalmology at Baylor College of Medicine in Houston, who detected a case of acanthamoeba keratitis, which is behind the current outbreak, on Friday.

    Acanthamoeba keratitis is caused by a parasite, can be difficult to detect and is hard to treat. This outbreak has involved at least 138 patients.

    Last year, an outbreak of fusarium keratitis was caused by a fungus; there were 164 confirmed cases. It was linked to ReNu With MoistureLoc made by Bausch & Lomb, but how the product caused the problem is unknown.

    Epidemiologists from the Centers for Disease Control and Prevention have linked the acanthamoeba keratitis outbreak to AMO Complete Moisture Plus Multi-Purpose Solution. Advanced Medical Optics of Santa Ana, Calif., manufactures the solution, which is used to clean and store soft contact lenses.

    AMO said there was no evidence to suggest that its product was contaminated with acanthamoeba and that it took its action as a precaution.

    Federal officials have advised consumers to stop using the solution immediately and to discard all partly used or unopened bottles and switch to alternative products.

    They have also advised people to throw out their current contact lenses and the lens storage cases because they may harbor the acanthamoeba parasite.

    And, officials said, those who have used the product should call an eye doctor if they have experienced eye pain or redness, blurred vision, sensitivity to light, the feeling of something in the eye or excessive tearing.

    The symptoms, which resemble those of other eye problems, can last weeks to months and vary among patients. The infection can lead to the need for a corneal transplant or removal of an eye.

    Acanthamoeba are ubiquitous and can be found in water, soil and spouts and sinks in a home. But why they cause so few cases among the estimated 35 million soft lens users in this country is a mystery.

    Investigations of the acanthamoeba outbreak are ongoing and being conducted by the disease control agency, the Food and Drug Administration, state and local health departments and eye doctors around the country.

    Dr. Jones, the Houston expert who has participated in the investigations, said doctors and health officials needed to monitor better the occurrence of corneal infections among contact lens users. He said he did not know whether the current outbreak would have been detected if last year’s had not been identified.

    Doctors also need to be more suspicious about the possibility of such infections because many cases have been initially attributed to the herpes simplex virus or other microbes, which respond to drugs that do not help patients with acanthamoeba, Dr. Jones said.

    Another need, he said, is to find more effective ways to notify the public and patients quickly about the removal of a product from the market because of a health hazard. The solution was still on shelves in several chain drug stores in Manhattan and Houston on Sunday.

    Dr. Jones said the two outbreaks indicated that environmental and other factors beyond contamination might be involved.

    Acanthamoeba infections have been reported in many countries. Dr. Jones’s team is credited for first identifying a corneal infection from acanthamoeba in the United States, in a rancher who was injured in an accident in Texas in 1973. That case did not involve contact lenses: while the rancher was working in a field, a piece of wire and hay hit his eye.

    He used irrigation water to wash it out and the eye became infected. A number of doctors whom the rancher consulted could not successfully treat it. With the aid of microbiologists at Baylor and the disease control agency in Atlanta, the team identified it as acanthamoeba.

    In the mid-1980s, doctors reported an acanthamoeba outbreak among contact lens users in this country.

    Recognition of the current outbreak has its origins in what seemed to be an increase in the number of cases found at the University of Illinois in Chicago over the last three years. The Illinois doctors reported the cluster to the disease control agency in March 2006.

    The agency then asked a number of eye centers in the United States to determine if they had noted an increase in cases; the findings were inconclusive.

    In January, the agency expanded its inquiry to 22 eye centers and found that 13 had an increase in cases since 2004. In mid-March, the agency said, it began a more extensive investigation.

    Dr. Jones’s team, which was among the researchers at the eye centers, found 16 confirmed cases since 2005, excluding the one on Friday. In 2004, Dr. Jones’s department treated 12 such cases.

    Scientists do not know how many acanthamoeba are needed to cause an infection or how much of a lens solution may be needed to cause damage.

    Investigators are exploring a variety of possibilities in seeking the cause of the outbreak. Among them is whether something like a change in chlorination practice has led to an increase in the number of acanthamoeba in certain water supplies.

    Investigators are also looking at the chemicals in the AMO solution, and whether the amoeba could bind more readily to newer generation silicone lenses, or whether something about certain kinds of contact lenses, or the length of their use, might increase the risk of infection among wearers.
    "Real wars of words are harder to win. They require thought, insight, precision, articulation, knowledge, and experience. They require the humility to admit when you are wrong. They recognize that the dialectic is not about making us look at you, but about us all looking together for the truth."

  2. #2
    But on the road more MTBLover's Avatar
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    Thanks for the heads-up Donna. I hadn't heard about this one. Between the B&L-associated fusarium outbreak (well, mini-outbreak, and just a series, really), and this one, there's a lot for us contact wearers to think about. I think that much of this is related to user behavior, bad examples of which seem to appear very frequently. One recent one- I was sitting on a plane waiting to take off, and a young woman seated across the aisle took a soft lens out of her eye and moistened it in her mouth. As she was positioning the lens on her finger to replace the lens on her cornea, I interrupted her and asked (nicely) "you're not really going to do that, are you?" To which she replied "Of course- I do it all the time- I never use solutions except to soak." Ugh.

    Although not a usual source of fusarium or acanthamoeba, the mouth is a pretty dirty place and offers up all sorts of microbial goodies that can result in a conjunctivitis or worse, keratitis. And dirty fingers (which can carry fusarium when they've had contact with contaminated soil) or reused or homemade solutions (which can serve as breeding grounds for acanthamoeba) are trouble, trouble, trouble. There are many, many more cases of staph-related keratitis, BTW- these amebic and fungal thingies are rare (although troubling because of the common exposures to the AMO or B&L solutions, respectively).

    So (putting on my epidemiologist hat...), the moral of the story is wash your hands always before handling your lenses or anything that comes into contact with them (cases, solution bottles), and never re-use solutions. And like Donna says, if you've been using AMO's solution, chuck what you have in the trash, along with any lenses and cases soaking in this.

  3. #3
    tired donnamb's Avatar
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    I hear you, MTBlover. I've been wearing soft lenses for 17 years now and have always been careful about hygeine. I'm even more cautious since I switched from lenses using heat disinfection to 30 day disposables about 8 years ago. That said, what a weird microbial infection - and to have such a strong connection with just one brand of saline solution. It doesn't help my head any that the beginning symptoms are pretty much identical to how my eyes always are during allergy season. Blech.

    I find it interesting that the saline solutions this time around and with last year's fungal infection have one thing in common - the "moisture protection" aspect. I really like that innovation - most allergy sufferers do. If that's somehow decreasing resistance to certain flora, though, I'll happily sacrifice it.
    "Real wars of words are harder to win. They require thought, insight, precision, articulation, knowledge, and experience. They require the humility to admit when you are wrong. They recognize that the dialectic is not about making us look at you, but about us all looking together for the truth."

  4. #4
    But on the road more MTBLover's Avatar
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    Donna- re: moisture protection- I caught that too. I thought that B&L Renu with Moisture-Lock was the best thing since sliced bread when it came out. I could wear my lenses up to 18 hours/day with no problem (and that, BTW, could be part of the problem with this stuff ) When the recall came out I almost switched to AMO's product, but decided to go with Ciba's Clear Care, if only because I liked the idea of the peroxide "scrubby bubbles"- they really do work, even as no-rub. The only problem I have had with this is that it's not moisturizing (I'm an allergy sufferer as well), but if I use moisturizing drops (like Aquify Comfort Drops) when the irritation is worst- maybe 1-2 times/day during the spring), I'm good.

    I'm thinking that the moisturizing solutions may provide a better habitat for these bugs, but the evidence is really unclear- they've never isolated them from the solutions, although I guess it's possible that solutions do something to the lenses that increase the risk of these infections in the presence of poor hygeine.

  5. #5
    Senior Member kwrides's Avatar
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    FWIW - I switched to Alcon Opti-Free Express after the Renu recall and I can now wear my contacts longer than ever before. I had been using B&L solution for 10+ years and was shocked at the difference.

  6. #6
    phony collective progress x136's Avatar
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    Once again, I'm glad I gave up on contacts and went back to glasses. No more sticking my fingers in my eyes, and no eyeball fungus! Yech!

  7. #7
    tired donnamb's Avatar
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    Ah, but being able to wear them longer than ever before might be part of the problem, kwrides. Even though they feel ok, keeping contacts in longer can cause irritation to the eye, which can lower resistance to infection even if you do maintain hygenic eye care practices.

    <sigh> I'll stick with contacts, though. I like having peripheral vision.
    "Real wars of words are harder to win. They require thought, insight, precision, articulation, knowledge, and experience. They require the humility to admit when you are wrong. They recognize that the dialectic is not about making us look at you, but about us all looking together for the truth."

  8. #8
    tired donnamb's Avatar
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    Quote Originally Posted by x136
    eyeball fungus!
    Ever grosser - eyeball protozoans!
    "Real wars of words are harder to win. They require thought, insight, precision, articulation, knowledge, and experience. They require the humility to admit when you are wrong. They recognize that the dialectic is not about making us look at you, but about us all looking together for the truth."

  9. #9
    Displaced Southerner polara426sh's Avatar
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    That's the stuff I had been using. I found out about the recall the same day my new contacts got here, so I didn't end up wasting a brand new pair.

  10. #10
    But on the road more MTBLover's Avatar
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    Quote Originally Posted by donnamb
    <sigh> I'll stick with contacts, though. I like having peripheral vision.
    Me too, and in my case, corrected presbyopia- no bifocals! And I can wear cool sunglasses (that I can afford) when riding

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