Dangerous Drug:

ReNu Contact Solution

Fusarium Keratitis Update

The Centers for Disease Control and Prevention (CDC) is continuing its investigation on the multi-state outbreak of Fusarium keratitis that may be associated with contact lens use. 

As of May 5, 2006, CDC has received reports of 102 confirmed cases, 12 possible cases and 81 cases still under investigation from 31 U.S. states and territories. 65 reports include insufficient evidence to classify them as cases or carry other non-Fusarium diagnoses.  States or territories with at least 1 confirmed or possible case include: AR, AZ, CA, CT, FL, GA, IA, IL, KS, KY, LA, MA, MD, MI, MO, NC, ND, NJ, NY, OH, PA, PR, TN, TX, and VT.  States where all cases under investigation include: IN, MN, NV, OK, OR, and RI.

Not all data are available for all confirmed cases. However, as of May 2, 2006, of the 58 confirmed cases for which CDC has complete data:

  • 56 wear contact lenses
  • 32 reported using any B&L ReNu with MoistureLoc
  • 15 reported using any B&L ReNu MultiPlus
  • 7 reported using any unspecified B&L ReNu
  • 3 reported using any AMO product
  • 3 reported using any Alcon product

* Some cases reported using more than one type of solution and therefore the solution categories are not mutually exclusive.

(Note: Updated case count numbers will be available on Tuesdays and Fridays.  Updated numbers on solution use and other pertinent exposures will be available on Tuesdays.)

Summary and Clarifications

In addition, CDC would like to clarify some of the information that has appeared in a number of recent media stories on the outbreak.  The following information is known related to this outbreak:

  • Since the first report on this outbreak in the April 10, 2006 Morbidity and Mortality Weekly Report (MMWR), CDC has noted that patients have reported using multiple products, including those manufactured by Bausch & Lomb, Alcon, and Advanced Medical Optics, Inc.
  • At this point, it is too early in the investigation to say whether a particular product or solution may be responsible for the outbreak.
  • Throughout the investigation, the proportion of patients who reported using Bausch & Lomb’s ReNu with MoistureLoc has remained relatively consistent, at around 50-60 percent of confirmed cases.
  • ReNu with MoistureLoc was used by approximately 2.3 million contact lens wearers in the United States, while MultiPlus was used by nearly 11 million contact lens wearers (branded or private label).
  • Fusarium keratitis is naturally occurring disease in the United States. It is not a disease that healthcare providers must report so it is unclear how many cases occur each year in the United States.
  • Disease outbreaks and increased media coverage often raise awareness about particular infections, which, in turn, may 1) increase reports of a disease and 2) result in additional information being identified and collected.  Thus, it is possible that some of the cases currently being investigated represent infection which might normally occur and, as a result, are not related to the outbreak.
  • The risk of getting fungal keratitis from contact lenses remains extremely low. Contact lens wearers who experience unusual redness, pain, tearing, light sensitivity, blurry vision, discharge or swelling should consult their doctor immediately.

CDC is continuing its investigation into identifying whether there are specific factors that may have placed people at risk for developing fungal keratitis, including hygiene practices, overnight contact lens wear and specific solutions used. The CDC will provide more information as it becomes available.

FDA Statement Regarding Voluntary Market Withdrawal of Bausch & Lomb ReNu MoistureLoc® Contact Lens Solution

FDA is continuing to work closely with the Centers for Disease Control and Prevention (CDC) and Bausch & Lomb to investigate the source of Fusarium keratitis eye infections. The agency supports Bausch & Lomb's decision to voluntarily withdraw ReNu MoistureLoc® contact lens solution from the market until the agencies have had a chance to conclude their investigation.

FDA started its investigation of the Bausch & Lomb manufacturing plant on March 22, 2006, and will continue inspections of the Greenville, SC manufacturing plant and other facilities through next week. While the investigation continues, FDA will work with CDC to identify and confirm cases of Fusarium keratitis reported by state health departments and from FDA Medwatch reports.

FDA and CDC are advising consumers to take precautions to reduce their risk for Fusarium keratitis through preventive practices for contact lens wearers that include:

  • 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 3-6 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.

For more information, please visit FDA’s Contact Lens and Eye Infections page at: http://www.fda.gov/oc/opacom/hottopics/contacts.html

Information Taken from the CDC and FDA.

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