Eye doctors have generally been concerned that bad hygienic habits among the 36 million U.S. contact lens wearers are increasing infection risks. Bad habits range from dirty lens cases to licking lenses to moisturize them and leaving bottles uncapped.

Even though multipurpose solutions like Complete MoisturePlus advertise “no rub” cleaning capability with FDA approval, doctors tend to advise patients to still rub their lenses clean. Such solutions have risen in popularity, but some doctors have questioned whether older cleaners like hydrogen peroxide are better defenders against this infection.

U.S. health investigators have linked the Complete MoisturePlus contact-lens solution made by Advanced Medical Optics to the outbreak of a rare but serious eye infection that can cause blindness.  The rare eye infection is called Acanthamoeba Keratitis.

U.S. health investigators have linked a contact-lens solution made by Advanced Medical Optics to the outbreak of a rare but serious eye infection that can cause blindness.

Advanced Medical Optics Inc., a California company, recalled its Complete MoisturePlus, a contact-lens cleaning solution, after an investigation sparked by the Chicago team found the solution was used by almost 60% of people suffering from a rare outbreak of infections by a microbe known as Acanthamoeba.

The Food and Drug Administration doesn’t require contact-lens solutions to kill amoebas, and they have never done so very successfully. Earlier this year, an Ohio State University team published research on how amoebas survived in three different cleaning solutions — from Bausch & Lomb Inc., Advanced Medical and Alcon Inc. After six hours of soaking, almost all of the strains of Acanthamoeba continued to grow in all three products.

Do I have an Acanthamoeba Keraitis Lawsuit?

If you or a loved one have developed a corneal infection (keratitis) while using any multi-purpose contact lens solution, you should contact us immediately. You may be entitled to compensation.

Click Here: Free Confidential Case Evaluation - AMO Complete MoisturePlus Recall

Learn More About: Acanthamoeba Keratitis

Source | Wall Street Journal

U.S. health investigators have linked a contact lens solution made by Advanced Medical Optics Inc. to the outbreak of a rare but serious eye infection that can cause blindness.

The news comes just a day after Advanced Medical Optics said it’s interested in exploring an offer for rival Bausch & Lomb Inc., which was hurt from the world-wide recall of a lens solution last year amid links to a different infection. The Advanced Medical Optics product at issue is called Complete MoisturePlus, one of several all-in-one-bottle solutions on the market.

As of Thursday, in a probe that includes 35 states and Puerto Rico, the U.S. Centers for Disease Control and Prevention has identified 138 “culture-confirmed” cases and has interviewed 46 patients.

Research shows 36 of those people wore soft contact lenses, 21 reported using the Advanced Medical Optics product a month before symptoms, and 14 used it exclusively. That was enough of a link to a product with limited market share to spark a public announcement, said Sharon Roy, medical epidemiologist with the CDC’s division of parasitic diseases.

“We felt we couldn’t wait,” she said in an interview late Friday. “We are recommending that people stop using this product and discard it” along with their lens case and current pair of contact lenses, she said. A spokeswoman from Advanced Medical Optics said the company had just learned about the issue Friday and is preparing a statement.

Eye infections from Acanthamoeba typically occur in contact lens wearers but are extremely rare, appearing on average in just one or two cases per million lens wearers per year. However, various eye-care centers around the U.S. have been tracking increased cases of the infection over the last three years.

The CDC’s interest in the recent outbreak was prompted by research done in the Chicago area at the University of Illinois at Chicago, led by Charlotte Joslin and Elmer Tu. They have tracked 67 cases of the outbreak in the Chicago area since June 2003, and had a paper on the matter accepted Friday for future publication in the American Journal of Ophthalmology. Ms. Joslin and Mr. Tu are both professors of ophthalmology at UIC.

According to Ms. Joslin, who is familiar with the CDC’s plans and research, the agency was expected to announce details regarding the infections and connections to the Advanced Medical Optics solution on Friday. The findings are very similar to what the UIC study uncovered in the Chicago area — in 55% of 38 cases where researchers had complete data, the Advanced Medical Optics solution was at issue, Ms. Joslin said of the local study.

That compares with the product’s approximate 10% market share, she said. Of all the risk factors researchers considers, “that’s the only one that’s statistically significant,” she said, although other factors like poor hygiene did stand out.

Other lens solutions were also used among infected people, but their usage was not considered statistically significant, Ms. Joslin said.

The product in question posted U.S. sales of $12.6 million in the first quarter, compared with overall company sales of $251.7 million.

Bausch & Lomb announced an agreement with private equity firm Warburg Pincus last week to be acquired for $3.67 billion, or $65 a share, but left the door open for competing bids. Advanced Medical Optics entered the fray on Thursday by saying it’s interested in exploring an offer.

Shares of Advanced Medical Optics were lower in after-hours trading after falling 2.2% to $40.20 during Friday’s regular trading session. Shares fell 3.2% on Thursday after the company announced interest in Bausch & Lomb.
Bausch & Lomb, Rochester, N.Y., completely pulled its ReNu with MoistureLoc lens solution from the world-wide market a year ago after it was associated with a fungal infection.

Hard To Treat

Acanthamoeba infections of the eye are very tough to treat and can lead to cornea transplants. The infection is also tough to detect, as it presents like common irritation. There are some topical medications that are specially formulated by pharmacies — one uses a form of swimming pool cleaner — but the infection becomes harder to fight topically as the amoeba drives into cornea.

“It’s a devastating type of infection,” said Thomas Steinemann, a professor at Case Western Reserve University and staff ophthalmologist at Metro Health in Cleveland, in a recent interview. “It’s a major problem to eradicate.”
Ms. Joslin, Mr. Tu and researchers at UIC have theorized that infection increases are linked to changing standards, under a U.S. Environmental Protection Agency mandate, to get certain harmful chemicals out of the water supply.
Amid the water connection, brought up in research by UIC last year, doctors have been stressing to avoid showering in contacts. They also advise against sleeping in them, even though some lenses have U.S. Food and Drug Administration approval for overnight wear.

Eye doctors have generally been concerned that bad hygienic habits among the 36 million U.S. contact lens wearers are increasing infection risks, an issue amplified by the Bausch & Lomb product trouble last year, when poor lens-care habits were seen as a factor. Bad habits range from dirty lens cases to licking lenses to moisturize them and leaving bottles uncapped.

Even though multipurpose solutions like Complete MoisturePlus advertise “no rub” cleaning capability with FDA approval, doctors tend to advise patients to still rub their lenses clean. Such solutions have risen in popularity, but some doctors have questioned whether older cleaners like hydrogen peroxide are better defenders against this infection.

U.S. health investigators have linked a contact-lens solution made by Advanced Medical Optics to the outbreak of a rare but serious eye infection that can cause blindness.

Do I have an Acanthamoeba Keraitis Lawsuit?

If you or a loved one have developed a corneal infection (keratitis) while using any multi-purpose contact lens solution, you should contact us immediately. You may be entitled to compensation.

Acanthamoeba Keraitis Lawsuit

Complete MoisturePlus Recall Lawsuit 

Two species of Acanthamoeba are most frequently diagnosed from eye infections: Acanthamoeba castellanii and Acanthamoeba polyphaga. Although Acanthamoeba species are common in the environment, the incidence of Acanthamoeba keratitis remains relatively rare, although studies suggest that infection may be more prevalent than suspected.

With the recent recall of Advanced Medical Optics Complete MoisturePlus Multi-Purpose Solution and the studies released by the U.S. Centers for Disease Control, we may begin to see the incidence of Acanthamoeba Keraitis begin to rise.

The abandonment of home-prepared saline and the widespread availability of multipurpose disinfecting solutions such as ReNu with MoistureLoc (Bausch & Lomb), Opti-free Express (Alcon), Solo-care Plus (Ciba Vision), and Complete MoisturePlusTM (Advanced Medical Options) may be a potential source of lens case and contact lens contamination of the Acanthamoeba species.

Do I have an Acanthamoeba Keraitis Lawsuit?

If you or a loved one have developed a corneal infection (keratitis) while using any multi-purpose contact lens solution, you should contact us immediately. You may be entitled to compensation.

Learn More: Acanthamoeba Keraitis Lawsuit

Source | U.S. Food & Drug Administration (FDA)

May 31, 2007

Dear Contact Lens Wearer,

FDA has learned of a recent increase of a rare but serious infection in people who wear soft contact lenses. The infection is Acanthamoeba keratitis, caused by a parasite that is commonly found in nature. It can cause a permanent loss of vision that can require corneal transplants, a surgical procedure to replace the clear outer covering of the eye. Early diagnosis of Acanthamoeba keratitis is important for treatment.

The Centers for Disease Control and Prevention (CDC) has confirmed 138 cases of Acanthamoeba keratitis in 35 different states. CDC has found an association between this infection and use of the Advanced Medical Optics (AMO) Complete® MoisturePlus Multi Purpose Solution, although at present nothing suggests that the product is contaminated.

Until more information becomes available, precautions are being taken to protect public health. On May 26, 2007, Advanced Medical Optics (AMO) voluntarily recalled all Complete® MoisturePlus Multi Purpose Solution. This means the company is removing all Complete® MoisturePlus Multi Purpose Solutions from store shelves. AMO is recommending that consumers stop using Complete® MoisturePlus Multi Purpose Solution immediately.

Investigations by CDC, FDA, state and local health departments, and AMO are underway to define specific behaviors or products that place contact lens wearers at increased risk for Acanthamoeba keratitis.
Recommendations for users of Complete® MoisturePlus Multi Purpose Solution

    * Remove your lenses andstop using Complete® MoisturePlus solution immediately.
    * Contact AMO at 1-888-899-9183 for instructions on what to do with unused solution.
    * Replace your contact lenses and storage case.
    * Ask your eye care professional about choosing another appropriate alternative cleaning/disinfecting product.

Safety tips for all contact lens wearers:

    * See your eye care professional immediately if you experience symptoms of eye infection such as redness, pain, excessive tearing, increased light sensitivity, blurry vision, and/or sensation of something in the eye.
    * Wear and replace your lenses according to the schedule prescribed by your eye care professional.
    * Remove your lenses before any activity involving water, including showering, using a hot tub, or swimming.
    * Wash your hands with soap and water, and dry them before handling your lenses.
    * Clean your lenses according to the manufacturer’s guidelines and instructions from your eye care professional.
          o Use fresh cleaning or disinfecting solution each time your lenses are cleaned and stored.
          o Never reuse or top off old solution.
          o Never use saline solution and rewetting drops to disinfect your lenses. Neither solution is an effective or approved disinfectant.
          o Ask your eye care professional if you should use a rub and rinse lens cleaning method rather than a no rub cleaning method.
    * Store your lenses in the proper storage case.
          o Rinse your storage case with sterile contact lens solution (never use tap water) and leave the storage case open to dry after each use.
          o Replace storage cases at least once every three months.

More information about contact lenses and eye care can be found at http://www.fda.gov/cdrh/contactlenses/.

If you have any concerns about your contact lenses, you should contact your eye care professional.

Additional information about Acanthamoeba infection is available from the CDC at http://www.cdc.gov/ncidod/dpd/parasites/acanthamoeba/index.htm.

If you have questions about AMO’s market recall contact FDA’s Division of Small Manufacturers, International and Consumer Assistance at 1-800-638-2041. For consumer information, select # 2.
Additional information on this topic for healthcare providers can be found at: http://www.fda.gov/cdrh/safety/053107-acanthamoeba.html

Do I Have an Advanced Medical Optics Complete MoisturePLUS Multi-Purpose Solution Recall Lawsuit?

If you or a loved one have developed a corneal infection (keratitis) while using any multi-purpose contact lens solution, you should contact us immediately. You may be entitled to compensation.

Schmidt & Clark, LLP Resources

Complete MoisturePLUS Recall

Acanthamoeba Keratitis

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Why you should choose Schmidt & Clark, LLP - Contact Lens Solution Litigation

Source | FDA Medwatch

Do I Have an Advanced Medical Optics Complete MoisturePLUS Recall Lawsuit?

If you feel that you may have developed Microbial Keratitis or Acanthamoeba Keratitis you should seek professional medical attention immediately. If left untreated, these infections could lead to blindness, vision loss or other serious side effects.

If you or a loved one have used Complete MoisturePLUS and developed an eye infection such as Microbial Keratitis or Acanthamoeba Keratitis, you should also contact us immediately. You may be entitled to compensation and we can help.

AMO Complete MoisturePLUS Recall

Source | CDC

Early Report of Serious Eye Infections Associated with Soft Contact Lens Solution

The Centers for Disease Control and Prevention (CDC), collaborating with the Food and Drug Administration, state and other partners, has identified an outbreak of a serious but rare eye infection called Acanthamoeba keratitis (AK). This infection is caused by a free-living ameba (Acanthamoeba) a microscopic organism found everywhere in nature. Infections can result in permanent visual impairment or blindness. AK primarily affects otherwise healthy people, most of whom wear contact lenses. In the United States, an estimated 85% of cases of this infection occur in contact lens users. The incidence of the disease in the U.S. is approximately one to two cases per million contact lens users.

CDC has received reports of 138 cases of culture-confirmed AK in 35 states and Puerto Rico, with complete patient data available for 46 case-patients.  Thirty-nine of the 46 case-patients wore soft contact lenses. Preliminary information obtained by CDC from patient interviews indicates that, among soft contact lens users who reported the use of any type of solution, 21 (58%) reported having used Advanced Medical Optics (AMO) Complete^R MoisturePlus^TM Multi-Purpose Solution in the month prior to symptom onset.  Out of the 37 case-patients for whom clinical data was available, 9 (24%) failed medical therapy and required or are expected to undergo corneal transplantation.

Based on these findings people who wear soft contact lenses who use Advanced Medical Optics (AMO) Complete^R MoisturePlus^TM Multi-Purpose Solution should:

·         Stop using the product immediately and discard all remaining solution including partially used or unopened bottles.  Choose an alternative contact lens solution.

·         Discard current lens storage container.

·         Discard current pair of soft lenses.

·         See a health care provider if experiencing any signs of eye infection: Eye pain, eye redness, blurred vision, sensitivity to light, sensation of something in the eye, or excessive tearing.

All contact lens users should closely follow prevention measures to help prevent eye infections, which include

·         See an eye care professional for regular eye examinations.

·         Wear and replace contact lenses according to the schedule prescribed by an eye care professional.

·         Remove contact lenses before any activity involving contact with water, including showering, using a hot tub, or swimming.

·         Wash hands with soap and water and dry before handling contact lenses.

·         Clean contact lenses according to the manufacturer’s guidelines and instructions from an eye care professional.

·         Use fresh cleaning or disinfecting solution each time lenses are cleaned and stored. Never reuse or top off old solution.

·         Never use saline solution and rewetting drops to disinfect lenses. Neither solution is an effective or approved disinfectant.

·         Store reusable lenses in the proper storage case.

·         Storage cases should be rinsed with sterile contact lens solution (never use tap water) and left open to dry after each use.

·         Replace storage cases at least once every three months

Clinicians evaluating contact lens users with symptoms of eye pain or redness, tearing, decreased visual acuity, discharge, sensitivity to light, or foreign body sensation should consider AK and refer the patient to an ophthalmologist, if appropriate. Diagnosis requires a high degree of suspicion, especially in a contact lens wearer with a recent diagnosis of another form of keratitis, such as herpes simplex virus keratitis, who is not responding to therapy.  Diagnosis is made on the basis of clinical picture and isolation of organisms from corneal culture or detection of trophozoites and/or cysts on histopathology.  However, a negative culture does not necessarily rule out Acanthamoeba infection. Confocal microscopy and polymerase chain reaction assays to detect Acanthamoeba may also assist with diagnosis. Early diagnosis can greatly improve treatment efficacy.

Clinicians should consider obtaining clinical specimens (e.g., corneal scrapings) for culture before initiating treatment. Clinicians or microbiology laboratories should report cases of AK to state and local health departments or directly to CDC at telephone, 770-488-7775. Acanthamoeba isolates should be submitted to state laboratories according to instructions provided by local and state public health laboratories.

For more information, see the CDC website: http://www.cdc.gov/ncidod/dpd/parasites/acanthamoeba/index.htm

Do I Have an Advanced Medical Optics Complete MoisturePLUS Recall Lawsuit?

If you feel that you may have developed Microbial Keratitis or Acanthamoeba Keratitis you should seek professional medical attention immediately. If left untreated, these infections could lead to blindness, vision loss or other serious side effects.

If you or a loved one have used Complete MoisturePLUS and developed an eye infection such as Microbial Keratitis or Acanthamoeba Keratitis, you should also contact us immediately. You may be entitled to compensation and we can help.

AMO Complete MoisturePLUS Recall

Source | CDC

In May 2006, the Illinois Department of Public Health (IDPH) informed CDC about a possible increase in Acanthamoeba keratitis (AK) at an ophthalmology center in Illinois during the preceding 3 years. The University of Illinois at Chicago (UIC) was investigating this possible increase. In October 2006, IDPH updated CDC about the ongoing UIC investigation. At that time, CDC informally contacted multiple ophthalmology centers in the United States to assess whether the potential increase in cases extended beyond Illinois. Responses from the ophthalmology centers were inconclusive. In January 2007, CDC initiated a retrospective survey of 22 ophthalmology centers nationwide to assess whether cases were increasing throughout the United States. In March 2007, data received from 13 centers demonstrated an increase in culture-confirmed cases of AK with wide geographic distribution. The increase in cases had begun in 2004 and continued to the present. On March 16, 2007, CDC initiated a multistate investigation to look for risk factors associated with this increase in AK cases. This report summarizes recent preliminary results of that investigation, which, indicated an association with AK in soft contact lens wearers who used Advanced Medical Optics (Santa Ana, California) Complete® MoisturePlus™ (AMOCMP) multipurpose cleaning solution. CDC and the Food and Drug Administration (FDA) are taking steps to notify the public and the medical and public health communities of this preliminary association. The manufacturer has undertaken a voluntary recall of the product.

AK, a rare but potentially blinding infection of the cornea, is caused by a ubiquitous, free-living ameba (Acanthamoeba) that is found commonly in the environment, including water (e.g., tap and recreational water), soil, sewage systems, cooling towers, and heating/ventilation/air conditioning (HVAC) systems. AK primarily affects otherwise healthy persons who wear contact lenses; an estimated 85% of U.S. cases occur in contact lens wearers (including wearers who follow recommended contact lens-care practices) (1). Persons who improperly store, handle, or disinfect their lenses (e.g., by using tap water or homemade solutions for cleaning); swim, use hot tubs, or shower while wearing lenses; come in contact with contaminated water; have minor damage to their corneas; or have previous corneal trauma are at increased risk for infection (2). Based on an analysis of cases reported to CDC during 1985–1987, the incidence of AK in the United States has been estimated at one to two cases per million contact lens users (3,4). An estimated 30 million persons in the United States wear soft contact lenses (5).

Initial case finding for this investigation was facilitated through postings on the Epidemic Information Exchange (Epi-X), on ophthalmology/optometry/infection control listservs and websites, and through queries of clinical microbiology laboratories. As of May 24, 2007, a total of 138 patients with onset of symptoms on or after January 1, 2005, and positive Acanthamoeba cultures from corneal specimens had been reported to CDC by public health authorities and ophthalmologists from 35 states and Puerto Rico. Standardized telephone interviews of patients, ophthalmologists, and primary eye-care providers are being conducted by state and local health officials and CDC. Laboratory testing of clinical specimens, contact lenses, bottles of solution, and contact lens cases received from AK patients, including typing of Acanthamoeba spp. isolates, is ongoing. An initial analysis was conducted using data from the first 46 completed patient interviews.

Among the 46 culture-confirmed patients who were interviewed, the median age was 40 years (range: 15–77 years); six (13%) were aged <18 years. Twenty-seven (59%) were female. Of the 37 of these patients for whom clinical data were available, medical therapy was unsuccessful for nine (24%), and they were required or expected to undergo corneal transplantation. Of the 46 patients, 39 (85%) wore soft contact lenses, three (7%) wore rigid lenses, and four (9%) reported no contact lens use. Among the 42 contact lens users, 16 (38%) reported swimming while wearing contact lenses and 35 (83%) reported showering while wearing contact lenses during the month before symptom onset.

Among the 39 soft contact lens users, 36 reported using one or more specific types of contact lens solution, 21 of these (58%) reported any use of AMOCMP in the month before symptom onset, 20 (56%) reported using AMOCMP as their primary solution, and 14 (39%) reported using AMOCMP as their exclusive solution. Exposure data from the 36 patients who wore soft contact lenses and used any type of contact lens solution were compared with exposure data from controls who were interviewed as part of the 2006 CDC Fusarium keratitis outbreak investigation (6). These controls, who were selected as geographically matched controls for the Fusarium keratitis cases, represented a sample of adult soft contact lens wearers from different U.S. states who were asked about product use and behaviors during March 2006 (6).

The 14 AK soft contact lens–wearing case-patients with symptom onset dates before April 1, 2006 (the period most comparable to Fusarium controls), who reported use of a single solution were compared with 115 controls from the Fusarium investigation who reported using a single solution. The results indicated that four (29%) of the 14 AK case-patients had used AMOCMP, compared with six (5%) of the 115 Fusarium controls (odds ratio: 7.3 [95% confidence interval (CI) = 1.7–30.1]). In a separate comparison, 36 soft contact lens–wearing AK case-patients with symptom onset dates before May 24, 2007, who reported use of one or more solutions were compared with 124 Fusarium controls who reported using one or more solutions. The results indicated that 21 (58%) of the 36 AK case-patients had used AMOCMP, compared with eight (6%) of the 124 Fusarium controls (odds ratio: 20.3; [CI = 7.6–53.9]). AMOCMP lot numbers were available for 10 patients who reported using the solution; no single lot number was repeated, suggesting that AMOCMP was not intrinsically contaminated. Analysis of the reported use of other brands of contact lens solution did not reveal any statistically significant associations.

The AK investigation by CDC, state and local health departments, FDA, and other partners, is continuing, and interviews of the remaining patients with culture-confirmed AK, their treating ophthalmologists, and their primary eye-care providers are ongoing. Although the results of initial analyses are preliminary, they suggest that use of AMOCMP increases the risk for AK. Additional studies will provide a more definitive assessment of the risk associated with use of AMOCMP. However, based on the preliminary findings, persons who wear soft contact lenses and who use AMOCMP should 1) stop using the product immediately and discard all remaining solution, including partially used or unopened bottles; 2) choose an alternative contact lens solution; 3) discard current lens storage container; 4) discard their current pair of soft lenses; 5) see a health-care provider if they experience any signs of eye infection, including eye pain or redness, blurred vision, sensitivity to light, sensation of something in the eye, or excessive tearing.

Contact lens users with questions regarding which solutions are best for them should consult their eye-care provider. Patients should also consult their eye-care provider if they have any of the following symptoms: eye pain or redness, blurred vision, sensitivity to light, sensation of something in the eye, and/or excessive tearing. AK symptoms, which can last several weeks to months, vary among patients. Early in the infection, symptoms can be similar to the symptoms of other more common eye infections; however, AK can result in vision loss or blindness if untreated.

All contact lens wearers should follow established guidelines to help reduce the risk for eye infections, including AK (Box). Primary-care clinicians evaluating contact lens users with symptoms of eye pain or redness, tearing, decreased visual acuity, discharge, sensitivity to light,Ep: or foreign body sensation should consider the diagnosis of AK and refer patients to an ophthalmologist, if appropriate. Diagnosis of AK requires a high degree of suspicion, especially in a contact lens wearer with a recent diagnosis of another form of keratitis, such as herpes simplex virus keratitis, who is not responding to therapy. Diagnosis of AK is based on clinical presentation and isolation of organisms from corneal culture or detection of trophozoites and/or cysts on histopathology. However, a negative culture does not necessarily rule out Acanthamoeba infection. Confocal microscopy and polymerase chain reaction assays to detect Acanthamoeba can also assist with diagnosis. Early diagnosis can greatly improve treatment efficacy.

Clinicians should consider obtaining clinical specimens (e.g., corneal scrapings) for culture before initiating treatment. Clinicians or microbiology laboratories should report cases of AK to state and local health departments or directly to CDC at telephone, 770-488-7775. Acanthamoeba isolates should be submitted to state laboratories according to instructions provided by local and state public health laboratories. Public inquiries should be made via telephone 800-CDC-INFO. Further information regarding Acanthamoeba infections is available at http://www.cdc.gov/ncidod/dpd/parasites/acanthamoeba/index.htm  

Do I Have an Advanced Medical Optics Complete MoisturePLUS Recall Lawsuit?

If you feel that you may have developed Microbial Keratitis or Acanthamoeba Keratitis you should seek professional medical attention immediately. If left untreated, these infections could lead to blindness, vision loss or other serious side effects.

If you or a loved one have used Complete MoisturePLUS and developed an eye infection such as Microbial Keratitis or Acanthamoeba Keratitis, you should also contact us immediately. You may be entitled to compensation and we can help.

AMO Complete MoisturePLUS Recall

Source | FDA

FOR IMMEDIATE RELEASE — (SANTA ANA, CA), May 25, 2007 – In response to information received today from the U.S. Centers for Disease Control and Prevention (CDC) regarding eye infections from Acanthamoeba, a naturally occurring water-borne organism which can contribute to serious corneal infections, Advanced Medical Optics is immediately and voluntarily recalling its Complete® MoisturePlusTM contact lens solutions. CDC data was made available to AMO today showing that it had completed interviews with 46 patients who had developed Acanthamoeba keratitis (AK) since January 2005. A total of 39 of these patients were soft contact lens wearers, 21 of whom reported using Complete® MoisturePlusTM products. The CDC estimates a risk of at least seven times greater for those who used Complete® MoisturePLUSTM solution versus those who did not.

While AMO continues to work with the CDC and the U.S. Food and Drug Administration (FDA) to further assess the data, it is acting with an abundance of caution to voluntarily recall Complete® MoisturePlusTM from the market. There is no evidence to suggest that today’s voluntary recall is related to a product contamination issue and this does not impact any of AMO’s other contact lens care products, including our family of hydrogen peroxide disinfecting solutions. As patient safety is paramount to AMO, the company is taking decisive action to stop shipments, recall product from the marketplace, and encourage consumers to discontinue the use of AMO Complete® MoisturePlusTM until further information is available. Given the potential seriousness of the reported Acanthamoeba infections, AMO is working in close partnership with the CDC, the FDA and others to make sure consumers are aware of the need for proper contact lens disinfection and proper lens handling.

Acanthamoeba is a microorganism commonly found in water, soil, sewage systems, cooling towers, and heating/ventilation/air conditioning (HVAC) systems. Acanthamoeba keratitis (AK) is a rare, but serious, infection of the cornea. 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. The incidence of AK in the United States has been estimated by CDC at approximately one to two cases per million contact lens users.

Contact lens wearers should consult with their eye doctor if they have any of the following symptoms: eye pain, eye redness, blurred vision, sensitivity to light, sensation of something in the eye, and excessive tearing. The symptoms, which can last several weeks to months, are not the same for everybody. Early in the infection, the symptoms of AK can be very similar to the symptoms of other more common eye infections but AK may eventually cause severe pain and possible vision loss with some patients requiring a corneal transplant if untreated.

Consumers who believe they are in possession of the recalled product should discontinue use immediately and call 1-888-899-9183. The company is currently contacting retailers, customers and distributors regarding return and replacement instructions. Reply cards and mailing slips are being provided for return of product. Retailers may also call 1-888-899-9183 for more information.

Please report any adverse reactions experienced with the use of this product and/or quality problems to AMO by calling 1-calling 1-800-347-5005 and to the FDA’s MedWatch Program by phone at 1-800-FDA- 1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

####

Do I Have an Advanced Medical Optics Complete MoisturePLUS Recall Lawsuit?

If you feel that you may have developed Microbial Keratitis or Acanthamoeba Keratitis you should seek professional medical attention immediately. If left untreated, these infections could lead to blindness, vision loss or other serious side effects.

If you or a loved one have used Complete MoisturePLUS and developed an eye infection such as Microbial Keratitis or Acanthamoeba Keratitis, you should also contact us immediately. You may be entitled to compensation and we can help.

AMO Complete MoisturePLUS Recall

Source | FDA

The U.S. Food and Drug Administration is alerting health care professionals and their patients who wear soft contact lenses about a voluntary recall of Complete MoisturePlus Multi Purpose Solution manufactured by Advanced Medical Optics of Santa Ana, Ca.

The company is taking this action as a precaution because of reports of a rare, but serious, eye infection, Acanthamoeba keratitis, 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).

Consumers who wear soft contact lenses should stop using the solution, discard all partially-used or unopened bottles and replace their lenses and storage container.

“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 Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. “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.”

Acanthamoeba keratitis may lead to vision loss with some patients requiring a corneal transplant. The infection primarily affects otherwise healthy people who wear contact lenses.

Consumers should ask their doctor about choosing an appropriate alternative cleaning/disinfecting product and seek immediate treatment if they have symptoms of eye infection as early diagnosis is important for effective treatment. The symptoms of Acanthamoeba keratitis can be very similar to those of other more common eye infections and may include eye pain or redness, blurred vision, light sensitivity, sensation of something in the eye or excessive tearing but Acanthamoeba is more difficult to treat.

It is estimated that Acanthamoeba keratitis infections occur in approximately 2 out of every 1 million contact lens users in the United States each year. However, in a multi-state investigation to evaluate a recent increase in Acanthamoeba keratitis cases, CDC determined that the risk of developing AK was at least seven times greater for those consumers who used Complete MoisturePlus solution versus those who did not. Additional information regarding the CDC results is available at the CDC website http://www.cdc.gov/mmwr/preview/mmwrhtml/mm56d526a1.htm.

“The ongoing CDC investigation is a collaborative effort,” said Michael Beach, M.D., a Division of Parasitic Diseases team leader with CDC. “We are working with FDA, state, territory, university, and clinical partners in an effort to further understand whether usage or contamination of this solution led to these Acanthamoeba infections.”

All contact lens users should closely adhere to the following measures to help prevent eye infections:

• Remove contact lenses before any activity involving contact with water, including showering, using a hot tub, or swimming.
• Wash hands with soap and water and dry them before handling contact lenses.
• Clean contact lenses according to manufacturer guidelines and instructions from an eye care professional. 
  • Use fresh cleaning or disinfecting solution each time lenses are cleaned and stored. Never reuse or top off old solution.
  • Never use saline solution and rewetting drops to disinfect lenses. Neither solution is an effective or approved disinfectant. 
• Schedule regular eye exams with your eye care professional
• Wear and replace contact lenses according to the schedule prescribed by your eye care professional.
• Store lenses in a proper storage case. 
  • Storage cases should be irrigated with sterile contact lens solution (never use tap water) and left open to dry after each use. 
  • Replace storage cases at least once every three months.

FDA and CDC want to gather information related to Acanthamoeba keratitis in contact lens users. Report adverse events related to these products to MedWatch, the FDA’s voluntary reporting program: www.fda.gov/medwatch/report.htm; Phone: (800) 332-1088; Fax: (800) 332-0178; Mail: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.

Consumers who believe they are in possession of the recalled product may call the company at 1-888-899-9183.

Additional information about Acanthamoeba infection is available from the CDC website at http://www.cdc.gov/ncidod/dpd/parasites/acanthamoeba/index.htm.

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Do I Have an Advanced Medical Optics Complete MoisturePLUS Recall Lawsuit?

If you feel that you may have developed Microbial Keratitis or Acanthamoeba Keratitis you should seek professional medical attention immediately. If left untreated, these infections could lead to blindness, vision loss or other serious side effects.

If you or a loved one have used Complete MoisturePLUS and developed an eye infection such as Microbial Keratitis or Acanthamoeba Keratitis, you should also contact us immediately. You may be entitled to compensation and we can help.

AMO Complete MoisturePLUS Recall