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Contact Lens Solution Recall - Thursday, May 31, 2007

AMO Announces Voluntary Recall of Complete® MoisturePlus(TM) Multipurpose Solution

SANTA ANA, Calif.--(BUSINESS WIRE)--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 (AMO) (NYSE:EYE) is immediately and voluntarily recalling its Complete® MoisturePlus(TM) 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® MoisturePlus(TM) products. The CDC estimates a risk of at least seven times greater for those who used Complete® MoisturePLUS(TM) 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® MoisturePlus(TM) 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® MoisturePlus(TM) 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 1-800-347-5005 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.

SOURCE: Advanced Medical Optics

If you have concerns that you maybe having adverse reactions or need care, call our office to make an appointment. You may also contact us by email also.

Eye Care Center of Northern Colorado, PC

(303) 772-3300

1400 Dry Creek Drive

Longmont, CO

300 Exempla Circle

Lafayette, CO

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Contact Lens Care Guidelines -

Proper lens care involves a combination of cleaning, disinfecting, rinsing, and wetting solutions. Surfactant cleaning solutions act like detergents to solubilize debris that is not chemically bonded to the lens. Rubbing the lens enhances the cleaning performance of the solution. Enzymatic cleaners remove deposits that are chemically bonded to the surface. Disinfecting solutions reduce the number of microorganisms carried on the lens. Wetting solutions make a water-repellant lens surface hydrophilic. Today many manufacturers combine these agents into multipurpose solutions.

An increase in the incidence of Acanthamoeba and fungal keratitis since 2004 has been noted. The etiology of this rise is currently being investigated1-6 but may be associated with inadequate antimicrobial efficacy of multipurpose solutions.

Lens cleaning and disinfection should be carefully explained to patients, since improper care may be associated with complications of lens wear. 7,8 Patients should be instructed to use only sterile products that are commercially prepared specifically for contact lens care and to replace these at the intervals recommended by the manufacturers.9 Patients should also be instructed to clean and replace contact lens cases frequently, since they can be a source of lens contamination.8,10 Damaged or cracked lens cases should be discarded. Directions for use of a no-rub solution require that a steady stream of the product be directed at the lens for a specific length of time. In general, however, rubbing the lenses during cleaning is considered to be a superior method of cleaning.

Patients should be instructed to replace the solution in contact lens cases each time the lenses are disinfected (i.e., old solution should not be topped off). The U.S. Food and Drug Administration has made the following recommendations for contact lens wearers regarding proper lens care practices: 11

  • Wash hands with soap and water, and dry (lint-free method) before handling lenses.
  • Wear and replace lenses according to the schedule prescribed by the doctor.
  • Follow the specific lens cleaning and storage guidelines from the doctor and the solution manufacturer.
  • Keep the contact lens case clean and replace every 3 to 6 months.
  • Remove the lenses and consult your doctor immediately if you experience symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge, or swelling.

REFERENCES

1. Centers for Disease Control and Prevention (CDC). Acanthamoeba Keratitis--Multiple States, 2005-2007. Morbidity Mortality Weekly Report, vol 56. Atlanta: US DHHS, PHS Publ No. RR-6; May 26, 2007.

2. Bernal MD, Acharya NR, Lietman TM, et al. Outbreak of Fusarium keratitis in soft contact lens wearers in San Francisco. Arch Ophthalmol 2006;124:1051-3.

3. Alfonso EC, Cantu-Dibildox J, Munir WM, et al. Insurgence of Fusarium keratitis associated with contact lens wear. Arch Ophthalmol 2006;124:941-7.

4. Chang DC, Grant GB, O'Donnell K, et al. Multistate outbreak of Fusarium keratitis associated with use of a contact lens solution. JAMA 2006;296:953-63.

5. Khor WB, Aung T, Saw SM, et al. An outbreak of Fusarium keratitis associated with contact lens wear in Singapore. JAMA 2006;295:2867-73.

6. Margolis TP, Whitcher JP. Fusarium--A new culprit in the contact lens case. JAMA 2006;296:985-7.

7. Nilsson SE, Montan PG. The annualized incidence of contact lens induced keratitis in Sweden and its relation to lens type and wear schedule: results of a 3-month prospective study. CLAO J 1994;20:225-30.

8. Bowden FW, 3rd, Cohen EJ, Arentsen JJ, Laibson PR. Patterns of lens care practices and lens product contamination in contact lens associated microbial keratitis. CLAO J 1989;15:49-54.

9. Acanthamoeba keratitis associated with contact lenses--United States. MMWR Morb Mortal Wkly Rep 1986;35:405-8.

10. Wilson LA, Sawant AD, Ahearn DG. Comparative efficacies of soft contact lens disinfectant solutions against microbial films in lens cases. Arch Ophthalmol 1991;109:1155-7.

11. U.S. Food and Drug Administration. Advice for patients with soft contact lenses: New information on risk of serious fungal infection. Available at: www.fda.gov/cdrh/medicaldevicesafety/atp/041006-keratitis.html. Accessed May 29, 2007.

Prepared by the American Academy of Ophthalmology Preferred Practice Patterns Refractive Management/Intervention PanelRefractive Management/Intervention Panel Members

Stephen D. McLeod, MD, ChairRoy S. Chuck, MD, PhDD. , Rex Hamilton, MD, James A. Katz, MD, Srilata S. Naidu, MD, Allan R. Rutzen, MD, FACS, John A. Vukich, MD, Susan Vitale, PhD, MHS

MethodologistPreferred Practice Patterns Committee Members

Sid Mandelbaum, MD, ChairEmily Y. Chew, MD, Linda M. Christmann, MD, Douglas E. Gaasterland, MD, Samuel Masket, MD, Stephen D. McLeod, MD, Christopher J. Rapuano, MD, Donald S. Fong, MD, MPH, Methodologist

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